|
Device | CYPHER SIROLIMUS-ELUTING CORONARY STENT ON THE RAPTOR OVER-THE-WIRE DELIVERY SYSTEM OR RAPTORRAIL RAPID EXCHANGE DELIVER |
Generic Name | Coronary drug-eluting stent |
Applicant | CORDIS CORP. 6500 Paseo Padre Parkway Fremont, CA 94555 |
PMA Number | P020026 |
Supplement Number | S005 |
Date Received | 07/02/2003 |
Decision Date | 11/17/2004 |
Withdrawal Date
|
08/28/2020 |
Product Code |
NIQ |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL FOR AN ADDITIONAL 500X VISUAL INSPECTION PRIOR TO CRIMPING. |