|
Device | 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 | S003 |
Date Received | 12/19/2000 |
Decision Date | 04/24/2001 |
Product Code |
MOU |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Postapproval Study Protocol |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE POST-APPROVAL STUDY PROTOCOL FOR THE BETA-CATH(TM) SYSTEM. THE 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 INVESTIGATION, ARE SUCCESSFUL IN REDUCING THE DEVICE FAILURE AND MALFUNCTION RATE. |
Post-Approval Study | Show Report Schedule and Study Progress |