|
Device | BOSTON SCITNTIFIC SCIMED AORTIC VALVULOPLASTY(TM) CATHETER |
Generic Name | PULSE-GENERATOR, PROGRAM MODULE |
Applicant | Boston Scientific Corp. One Scimed Place Maple Grove, MN 55311 |
PMA Number | P880065 |
Supplement Number | S006 |
Date Received | 07/12/2001 |
Decision Date | 07/30/2001 |
Withdrawal Date
|
09/20/2007 |
Product Code |
LOT |
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 A MODIFICATION TO THE WARNING STATEMENT IN THE DIRECTIONS FOR USE MANUAL TO EXPAND ON THE POTENTIAL AFFECT OF RE-PROCESSING OR RE-STERILIZATION. |