Contak Renewal 3

제조사

  • 제조사 모회사 (2017)
  • 제조사 의견
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    SATP

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 24 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    all serial numbers
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    worldwide. Including United States, Virgin Islands and countries such as Argentina, Australia, Austria, Barbados, Belgium, Bermuda, Canada, Cayman Islands, Chile, Colombia, Cyprus, Czech Republic, Denmark, Eygpt, Finland, France, Germany, Greece, Guadeloupe, Guam, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Labanon, Luxembourg, Marshall Islands, Mexico, Netherlands, New Zealand, Northern Mariana Islands, Norway, Peru, Portugal, Qatar, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, Tunisia, Turkey, United Kingdom and Venezuela.
  • 제품 설명
    CONTAK RENEWAL 3 CRT-D (model no. H170, H173, H175) and CONTAK RENEWAL 3 HE CRT-D(model no. H177 and H179). Cardiac Resynchronization Therapy Defibrillator. Sterilized with gaseous ethylene oxide. Guidant Corporation, Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 5511-5798 USA. CONTAK RENEWAL 3 devices provide ventricular tachyarrhythmia and cardiac resynchronization therapies.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    all serial numbers
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    worldwide. Including United States, Virgin Islands and countries such as Argentina, Australia, Austria, Barbados, Belgium, Bermuda, Canada, Cayman Islands, Chile, Colombia, Cyprus, Czech Republic, Denmark, Eygpt, Finland, France, Germany, Greece, Guadeloupe, Guam, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Labanon, Luxembourg, Marshall Islands, Mexico, Netherlands, New Zealand, Northern Mariana Islands, Norway, Peru, Portugal, Qatar, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, Tunisia, Turkey, United Kingdom and Venezuela.
  • 제품 설명
    CONTAK RENEWAL 3 AVT CRT-D (model no. M150 and M155) and CONTAK RENEWAL 3 AVT HE CRT-D(model no. M157 and M159) Cardiac Resynchronization Therapy Defibrillator. Sterilized with gaseous ethylene oxide. Guidant Corporation, 4100 Hamiline Avenue North, St. Paul, MN 55112-5798 USA. CONTAK RENEWAL 3 AVT devices provide both atrial and ventricular tachyarrhythmia and cardiac resynchronization therapies.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Issue affecting devices is a pre-implant issue. Serial number ranges listed below may also include devices not affected (i.e. implanted devices).  Model H210 serial number 200031 thru 202462.  Model H215 serial numbers 700016 thru 702646.  Model H217 serial numbers 700006 thru 702543.  Model H219 serial numbers 200021 thru 201747.  Model H230 serial numbers 100012 thru 200526.  Model H235 serial numbers 100018 thru 650559.  Model H239 serial numbers 100018 thru 650272.
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Nationwide, Puerto Rico, Virgin Islands and to countries that include: Austria, Belgium, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Iran, Ireland, Israel, Italy, Luxembourg, Mexico, Netherlands, Norway, Portugal, Saudi Arabia, Slovakia, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom
  • 제품 설명
    CONTAK RENEWAL 3 RF (models H210, H215), CONTAK RENEWAL 3 RF HE (models H217, H219), CONTAK RENEWAL 4 RF (models H230, H235) CONTAK RENEWAL 4 RF HE (model H239) cardiac resynchronization therapy defibrillator (CRT-D), provide ventricular tachyarrhythmia and cardiac resynchronization therapies. Ventricular tachyarrhythmia therapy is for the treatment of ventricualar tachycardia (VT) and ventricular fibrillation (VF), rhythms that are associated with suden cardiac death (SCD). Cardiac resynchronization therapy is for the treatment of heart failure (HF) and uses biventricular electrical stimulation to synchronize ventricular contractions. The device also uses accelerometer-based adaptive-rate bradycardia therapy. These CONTAK RENEWAL RF devices feature enhanced telemetry communication with wandless ZIP telemetry. Cardioversion/defibrillation therapies include a range of low- and high-energy shocks using either a biphasic or monophasic waveform. Guidant Corporation, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    model H170, serial numbers: 509659, 509677, 509678,  509679, 509685, 509694, 509695, 509696, 509762, 509884,  509974, 510012   model H175, serial numbers: 512665, 512666, 512667, 512668, 512708, 512709, 512710, 512711, 512713, 512719,  512721, 512722, 512723, 512759, 512791, 512793, 513062,  513064, 513073, 513085, 513086, 513227   model H177, serial numbers: 506951, 506953, 506954,  506955, 506956, 506957, 506959, 506960, 506967, 506969,  506970, 506973, 506974, 507013, 507014, 507472   model H179, serial numbers: 508312, 508316, 508322,  508325, 508326, 508336, 508342, 508349, 508404
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Nationwide including Puerto Rico. Worldwide, including Argentina, Belgium, Canada, Denmark, France, Germany, Greece, Ireland, Italy, Netherlands, New Zealand, Portugal, Spain, Syrian Arab Republic, United Arab Emirates
  • 제품 설명
    Guidant CONTAK RENEWAL 3 (models H170, H175) CONTAK RENEWAL 3 HE (models H177, H179) Cardiac Resynchronization Therapy Defibrillator (CRT-D). Guidant Corporation, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Cardiac resynchronization therapy defibrillators (CRT-D) provide ventricular tachyarrhythmia and cardiac resynchronization therapies. Ventricular tachyarrhythmia therapy is for the treatment of ventricular tachycardia (VT) and ventricular fibrillation (VF), rhythms that are associated with sudden cardiac death (SCD). Cardiac resynchronization therapy is for the treatment of heart failure (HF) and uses biventricular electrical stimulation to synchronize ventricular contractions. Cardioversion/defibrillation therapies include a range of low-and high-energy shocks using either a biphasic or monophasic waveform.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Devices that are implanted subpectorally with the serial number facing the ribs. Implant orientation is not reported to Guidant.
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Nationwide, US Virgin Islands, Puerto Rico and worldwide to include: Argentina, Aruba, Australia, Austria, Barbados, Belgium, Bermuda, Brazil, Canada, Cayman Islands, Chile, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Germany, Greece, Guadeloupe, Guam, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Korea, Kuwait, Lebanon, Luxembourg, Malaysia, Marshall Islands, Mexico, Netherlands, New Zealand, Northern Mariana Islands, Norway, Peru, Polynesia, Portugal, Qatar, Russia, Saint Lucia, Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, Tunisia, Turkey, United Kingdom, Uruguay, Venezuela, West Indies.
  • 제품 설명
    Guidant CONTAK RENEWAL 3 (models H170, H173, H175), CONTAK RENEWAL 3 HE (models H177, H179) CONTAK RENEWAL 4 (models H190, H195), CONTAK RENEWAL 4 HE (models H197, H199). Cardiac Resynchronization Therapy Defibrillator (CRT-D). Sterile EO. Guidant Corporation, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Cardiac resynchronization therapy defibrillators (CRT-D) provide ventricular tachyarrhythmia and cardiac resynchronization therapies. Ventricular tachyarrhythmia therapy is for the treatment of ventricular tachycardia (VT) and ventricular fibrillation (VF), rhythms that are associated with sudden cardiac death (SCD). Cardiac resynchronization therapy is for the treatment of heart failure (HF) and uses biventricular electrical stimulation to synchronize ventricular contractions. Cardioversion/defibrillation therapies include a range of low- and high-energy shocks using either a biphasic or monophasic waveform.
  • Manufacturer
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