|
Device | GUARDIAN CORONARY BALLOON DILATATION PTCA CATHETER |
Generic Name | Catheters, transluminal coronary angioplasty, percutaneous |
Regulation Number | 870.5100 |
Applicant | ABBOTT VASCULAR DEVICES 400 SAGINAW DR. REDWOOD CITY, CA 94063 |
PMA Number | P910031 |
Supplement Number | S017 |
Date Received | 10/14/1997 |
Decision Date | 11/10/1997 |
Reclassified Date
|
10/08/2011 |
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 Approval for a change in the trade name from the LYNX(TM) to the Guardian(TM) Coronary Balloon Dilatation PTCA Catheter. |