|
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 | S002 |
Date Received | 11/17/2000 |
Decision Date | 12/18/2000 |
Product Code |
MOU |
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 ADDITION OF A NEW QUALITY CONTROL TEST METHOD DURING THE MANUFACTURING PROCESS OF THE B-CATH(TM) DELIVERY CATHETER. |
Post-Approval Study | Show Report Schedule and Study Progress |