ela Medical Llc

001YH026 811YH056 824YH071 825YH049 825YH089 828YH052 835YH018 836YH016 836YH057 837YH041 851YH00B 903YH050 903YH05F 904YH018 904YH01B 904YH038 907YH017 907YI037 907YI041 909YI036 912YH049 912YH057 912YI009 912YI00A 912YI011 912YI025 912YI026 912YI028 912YI02B 912YI031 912YI048 914YI005 915YH012 915YH014 915YH041 916YH020 916YH028 916YH032 917YH002 917YH003 917YH024 917YH03F 918YH045 918YI029 918YI0A2 919YH02F 919YH03D 919YH044 919YH064 920YI085 920YI089 920YI092 922YH01C 923YH012 923YH023 923YH048 924YH01E 924YH02D 924YH046 925YH015 925YH032 926YH00D 926YH020 926YH037 926YH042 926YH05F 926YI012 926YI032 927YH01A 927YH030 928YH004 928YH01A 928YH033 928YH035 928YI024 928YI02C 928YI045 928YI070 929YH00B 929YH00D 929YH012 929YH019 929YH01C 929YH022 929YH023 929YH033 929YH055 929YI014 929YI030 931YH004 931YH018 931YH035 931YH037 931YH044 931YH04C 931YH052 931YH053 931YH057 931YH059 931YH05E 931YH061 931YH062 931YH063 931YH065 931YH068 931YH069 931YH06B 931YH06C 931YH070 931YH071 931YH072 931YH074 931YH075 931YH07A 931YH081 931YH084 931YI038 931YI066 932YH00B 932YH02E 932YH032 932YH039 932YH03B 932YH04D 932YH052 932YH065 932YH06B 932YH073 932YH0A3 932YH0AD 932YH0B4 932YH0BE 932YI011 932YI08C 933YH007 933YH009 933YH01F 933YH030 933YH060 933YH09D 933YH100 933YH103 933YH105 933YH111 934YH01A 934YH02A 934YH044 934YH04A 935YH005 935YH006 935YH007 935YH015 935YH01D 935YH045 935YH048 935YH058 936YH014 936YH01B 936YH01C 936YH01E 936YH021 936YH023 936YH03A 936YH041 936YH047 936YH062 936YH064 936YH06D 936YH06F 936YH071 936YH078 936YH082 936YH083 937YH01D 937YH022 937YH025 937YH02B 938YH005 938YH01A 938YH01D 938YH03F 939YH00A 939YH02D 940YH005 940YH041 940YH042 940YH057 940YH05A 940YH061 941YH043 942YH02C 943YH01E 943YH025 944YH032 945YH004 945YH00C 945YH01A 945YH053 947YH003 947YH017 947YH01B 947YH01E 947YH027 947YH036 947YH053 947YH057 947YH062 948YH031 948YH037 948YH03B 949YH064 949YH07F 949YH081 949YH084 949YH092

Cardiovascular Devices

3

Yes

Nationwide Distribution in the states of AZ, CA, FL, IA, LA, MA, MS,MO, NJ, NY, NC, OH, OK, PA, SC, TN, TX, and VA.

Sorin Paradym CRT-D Model 8750 and Sorin Group Paradym sonR CRT-D Model 8770. || Made in Italy by Sorin Biomedical CRM S.r.l. Via Crescentino s.n. , 13040 Saluggia (VC) Italy

Serial 001YF024 004YF005 004YF019 004YF05C 004YF058 004YF081 004YF082 004YF084 005YF068 006YF075 008YF057 013YF04E 016YF02A 016YF049 016YF055 016YF058 017YF014 018YF00C 018YF01F 021YF03B 021YF031 021YF048 022YF01B 022YF02F 022YF03B 022YF031 022YF037 022YF043 022YF05A 022YF058 022YF067 023YF0B1 023YF016 023YF03F 023YF04C 023YF045 023YF089 023YF104 023YF12A 023YF129 023YF162 023YF173 024YF005 024YF034 025YF0B0 025YF0B4 025YF0C1 025YF0F2 025YF0F8 025YF06B 025YF07E 025YF08E 025YF094 025YF096 025YF117 026YF0BD 026YF0B0 026YF0E4 026YF02F 026YF028 026YF033 026YF06D 026YF068 026YF08F 028YF007 028YF01A 028YF01F 029YF001 029YF016 029YF03E 029YF05C 029YF1B5 029YF1DF 029YF11E 029YF15D 029YF204 030YF0E9 030YF004 030YF03F 030YF030 030YF061 030YF073 030YF1C2 030YF131 030YF139 030YF145 030YF152 030YF155 030YF16F 031YF039 032YF005 034YF011 034YF014 034YF016 034YF018 034YF024 037YF085 038YF065 041YF057 904YF033 932YF013 935YF010 936YF076 945YF024 003YG06D 004YG00D 004YG003 004YG012 004YG017 004YG03E 004YG031 004YG04F 004YG042 004YG043 004YG05A 004YG05D 004YG053 004YG056 004YG06F 004YG063 004YG064 004YG07E 004YG075 005YG00A 005YG048 005YG06B 005YG070 005YG074 005YG08F 006YG089 008YG03F 014YG03E 014YG092 015YG07B 016YG023 016YG026 016YG029 016YG04A 016YG04C 016YG05C 017YG00F 017YG03A 017YG050 018YG00F 018YG059 019YG032 020YG00D 020YG00F 020YG001 020YG01B 020YG017 020YG020 020YG026 020YG027 020YG03A 020YG035 021YG01E 021YG04C 021YG041 022YG026 022YG044 022YG069 023YG0B2 023YG0B3 023YG0C0 023YG01A 023YG086 023YG094 023YG101 023YG108 023YG137 023YG14D 023YG148 023YG16A 023YG16B 023YG160 023YG17A 024YG025 024YG044 024YG064 024YG07A 024YG08E 024YG08F 025YG0A3 025YG0A6 025YG05C 025YG064 025YG080 025YG095 025YG113 025YG119 026YG0A5 026YG0A9 026YG0B2 026YG0D1 026YG03C 026YG035 026YG036 026YG037 026YG038 026YG071 026YG08C 026YG090 026YG096 026YG098 026YG112 028YG037 029YG0C7 029YG0DA 029YG02A 029YG079 029YG08D 029YG1AD 029YG12A 029YG12C 029YG169 029YG178 029YG19A 030YG0AB 030YG0A0 030YG0BD 030YG0B7 030YG0EB 030YG0E2 030YG0E8 030YG0F0 030YG0F6 030YG039 030YG063 030YG1AC 030YG11F 030YG13C 030YG134 030YG14A 030YG14F 030YG141 030YG144 030YG149 030YG160 030YG17A 030YG195 031YG01C 031YG01D 031YG02D 031YG055 032YG0C9 032YG001 032YG003 032YG017 032YG029 032YG033 032YG035 032YG036 032YG054 032YG058 032YG067 032YG081 034YG00A 034YG00D 034YG03D 034YG041 034YG046 034YG051 037YG0B7 037YG0CC 037YG0D0 037YG067 041YG05D 835YG073 923YG037 925YG006 933YG0B9 944YG005 945YG005 947YG005

Cardiovascular Devices

3

Yes

Nationwide Distribution including AL, AZ, AR, CA, CO, CT, FL, GA, IA, MA, MI, MO, MS, NJ, NY, NC, OH, OK, PA, SC,A TN,T X, and WA.

Paradym DR Model 8550 and Paradym VR Model 8250, Sterile EO, Manufactured in Italy by Sorin CRM S. r.l., Via Crescentino s.n., 13040 Saluggia(VC) Italy || PARADYM DR 8550 and PARADYM VR 8250 are indicated for use in patients who are at high risk of sudden cardiac death due to ventricular tachyarrhythmias and who have experienced one of the following situations: Survival of at least one episode of cardiac arrest (manifested by the loss of consciousness) due to ventricular tachyarrhythmia, recurrent, poorly tolerated sustained ventricular tachycardia (VT).