|
Device | PROSTAR TM 8FR AND 10FR PVS AND PROSTAR XL |
Applicant | ABBOTT VASCULAR INC. 400 Saginaw Drive Redwood City, CA 94063 |
PMA Number | P960043 |
Supplement Number | S003 |
Date Received | 10/02/1997 |
Decision Date | 11/18/1997 |
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 changes tot he Precautions and Clinical Procedure sections of the Instructions for Use. |