|
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 | S017 |
Date Received | 08/27/2001 |
Decision Date | 09/26/2001 |
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 DRYING OPERATION OF THE BETA-CATH(TM) DELIVERY CATHETER. |
Post-Approval Study | Show Report Schedule and Study Progress |