|
Device | NC MERLIN PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (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 | S026 |
Date Received | 07/29/2009 |
Decision Date | 08/26/2009 |
Reclassified Date
|
10/08/2011 |
Product Code |
LOX |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement CHANGE IN THE EQUIPMENT USED TO MANUFACTURE THE BALLOONS. |