AGA AMPLATZER Vascular Plug

The three lots that were distributed are identified as Lot no. M05F10-11, M05F15-12 and M05F02-47.

Cardiovascular Devices

2

Yes

OUS countries include: Australia, Germany, Italy, Korea, Malasia, Slovakia, Spain, Switzerland, Thailand, United Kingdom

AMPLATZER Vascular Plug, Manufactured by AGA Medical Corporation , 682 Mendelssohn Avenue, Golden Valley, MN 55427 USA. Sterile EO. Single Use Only. Rx Only. Do not use open or damaged packages. Store in a cool, dry place. The AMPLATZER Vascular Plug is a self-expandable, cylindrical device made from a Nitinol wire mesh. The device is secured on both ends with platinum marker bands. A stainless steel micro screw is welded to one of the platinum marker bands, which allows attachment to the 135 cm long deliver cable. The AMPLATZER Vascular Plugs are made in various sizes ranging from 4 to 16 mm in 2 millimeter increments.