|
Device | TAXUS EXPRESS PACLITAXEL-ELUTING CORONARY STENT SYSTEM |
Generic Name | Coronary drug-eluting stent |
Applicant | Boston Scientific Corp. ONE SCIMED PLACE MAPLE GROVE, MN 55311-1566 |
PMA Number | P030025 |
Supplement Number | S018 |
Date Received | 03/30/2005 |
Decision Date | 04/13/2005 |
Withdrawal Date
|
12/06/2018 |
Product Code |
NIQ |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement ALTERNATIVE ANALYTICAL METHOD TO BE USED FOR THE NON-COMPENDIAL FUNCTIONAL EXCIPIENT ANALYSIS OF POLY (STYRENE-ISOBUTYLENE-STYRENE) TRI-BLOCK COPOLYMER, SIBS IN THE TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM. |