|
Device | BOSTON SCINTIFIC SCIMED PTCA CATHETER |
Generic Name | Catheters, transluminal coronary angioplasty, percutaneous |
Regulation Number | 870.5100 |
Applicant | BOSTON SCIENTIFIC One Scimed Place Maple Grove, MN 55311 |
PMA Number | P880027 |
Supplement Number | S060 |
Date Received | 07/12/2001 |
Decision Date | 07/30/2001 |
Withdrawal Date
|
04/13/2007 |
Product Code |
LOX |
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. |