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 | S016 |
Date Received | 08/07/2001 |
Decision Date | 01/30/2002 |
Product Code |
MOU |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Postapproval Study Protocol |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE REVISED POST-APPROVAL STUDY PROTOCOL FOR THE 30 MM AND 40 MM BET SYSTEMS. THE REVISED POST-APPROVAL STUDY IS INTENDED TO VERIFY THAT THE CORRECTIVE ACTIONS, INTENDED TO HELP MINIMIZE THE INCIDENCE OF DEVICE FAILURES AND MALFUNCTIONS SEEN DURING THE PREMARKET CLINICAL INVESTIGATIONS, ARE SUCCESSFUL IN REDUCING THE DEVICE FAILURE AND MALFUNCTION RATE. |
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