|
Device | NOVOSTE(TM) BETA-CATH SYSTEM |
Generic Name | Intravascular radiation delivery system |
Applicant | BEST VASCULAR, INC 4350 INTERNATIONAL BOULEVARD NORCROSS, GA 30093 |
PMA Number | P000018 |
Supplement Number | S023 |
Date Received | 07/18/2002 |
Decision Date | 07/31/2002 |
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 CHANGE IN THE MANUFACTURING PROCESS TO IMPLEMENT A NEW PROCESS OF APPLYING THE O-RINGS TO THE PROPRIETARY CONNECTOR USING AN O-RING INSTALLATION TOOL. |