|
Device | TECHSTAR XL & PROSTAR XL PERCUTANEOUS VASCULAR SURGICAL (PVS) SYSTEM |
Applicant | ABBOTT VASCULAR INC. 400 Saginaw Drive Redwood City, CA 94063 |
PMA Number | P960043 |
Supplement Number | S018 |
Date Received | 04/22/1999 |
Decision Date | 05/26/1999 |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the use of an additional package label identifying the sterile barrier. |