|
Device | PYROGEN TESTING OF ACS/CORNARY DILATATION CATHETERS E-BEAM- RADIATION STERILIZER |
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 | S187 |
Date Received | 01/26/1998 |
Decision Date | 12/28/1998 |
Reclassified Date
|
10/08/2010 |
Product Code |
LOX |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval to conduct pyrogen testing of ACS Coronary Dilatation Catheters prior to sterilization by E-beam radiation. |