|
Device | GOLDIE TM AND GOLDIE TM LONGY 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 | S044 |
Date Received | 01/07/1997 |
Decision Date | 02/19/1997 |
Withdrawal Date
|
04/13/2007 |
Product Code |
LOX |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement INCREASE IN RATED BURST PRESSURE FOR THE GOLDIE(TM) AND GOLDIE(TM) LONGY PTCA CATHETERS. |