|
Device | POWERSAIL/HIGHSAIL CORONARY DILATION CATHETERS |
Generic Name | Catheters, transluminal coronary angioplasty, percutaneous |
Applicant | ADVANCED CARDIOVASCULAR SYSTEMS, INC. 26531 YNEZ RD. TEMECULA, CA 92591 |
PMA Number | P810046 |
Supplement Number | S211 |
Date Received | 12/26/2001 |
Decision Date | 02/22/2002 |
Reclassified Date
|
10/08/2010 |
Product Codes |
DYG LOX |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A SINGLE PROCESS CHANGE CONCERNING THE TEMPERATURE FOR THE ACCELERATING AGING PROTOCOL FOR THE SHELF-LIFE TESTING OF THE POWERSAIL AND HIGHSAIL CORONARY DILATATION CATHETERS. |