|
Device | ACS RX COMET VP CORONARY DILATATION CATHETER (OTHER DILATATION CATHETERS) |
Generic Name | Catheters, transluminal coronary angioplasty, percutaneous |
Regulation Number | 870.5100 |
Applicant | ADVANCED CARDIOVASCULAR SYSTEMS, INC. 26531 YNEZ RD. TEMECULA, CA 92591 |
PMA Number | P810046 |
Supplement Number | S196 |
Date Received | 12/22/1998 |
Decision Date | 01/22/1999 |
Reclassified Date
|
10/08/2010 |
Product Code |
LOX |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the implementation of an additional quality control inspection to further ensure that hte balloon size designation on the proximal adaptor is correct fo rthe ACS RX Comet VP(TM) Coronary Dilatation Catheter and the other ACS Coronary Dilatation Catheters listed in the supplement. |