Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
|
Device | NIR W/SOX PREMOUNTED STENT SYSTEM |
Applicant | Boston Scientific Corp. One Boston Scientific Place Natick, MA 01760 |
PMA Number | P980001 |
Supplement Number | S011 |
Date Received | 07/28/1999 |
Decision Date | 03/16/2000 |
Withdrawal Date
|
08/13/2007 |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the NIR (TM) w/SOX(TM) Premounted Stent System. |
|
|