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 | EXPRESS SD RENAL PREMOUNTED STENT SYSTEM |
Generic Name | STENT, RENAL |
Applicant | Boston Scientific Corp. ONE SCIMED PLACE MAPLE GROVE, MN 55311-1566 |
PMA Number | P060006 |
Supplement Number | S001 |
Date Received | 11/05/2009 |
Decision Date | 12/04/2009 |
Product Code |
NIN |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement ADDITION OF AN ANALYTICAL TEST METHOD. |
|
|