|
Device | BONNIE SLIDING RAIL PTCA CATHETERS |
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 | S053 |
Date Received | 10/24/1997 |
Decision Date | 11/21/1997 |
Withdrawal Date
|
04/13/2007 |
Product Code |
LOX |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a 3 and 1/2 year shelf life for the Bonnie(TM) Slidng Rail Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters. |