|
Device | NOVOSTE TM BETA-CATH TM SYSTEM |
Generic Name | Intravascular radiation delivery system |
Applicant | BEST VASCULAR, INC 4350 INTERNATIONAL BOULEVARD NORCROSS, GA 30093 |
PMA Number | P000018 |
Supplement Number | S030 |
Date Received | 02/07/2003 |
Decision Date | 02/26/2003 |
Product Code |
MOU |
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 ALTERNATE METHOD OF MANUFACTURE FOR THE LEAK TESTING AND DRYING OPERATION OF THE BETA-RAIL 3.5F DELIVERY CATHETER. |