Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | NOVOSTE BETA-CATH SYSTEM |
Generic Name | Intravascular radiation delivery system |
Applicant | BEST VASCULAR, INC 4350 INTERNATIONAL BOULEVARD NORCROSS, GA 30093 |
PMA Number | P000018 |
Supplement Number | S025 |
Date Received | 10/15/2002 |
Decision Date | 01/06/2003 |
Product Code |
MOU |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR MODIFICATIONS TO THE DESIGN SPECIFICATION AND MANUFACTURING PROCESS FOR THE BETA-RAIL 3.5F DELIVERY CATHETER (WITH 30 AND 40 MM INDICATOR SOURCE TRAIN). |
Post-Approval Study | Show Report Schedule and Study Progress |
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