NOVOSTE BETA-CATH SYSTEM
FDA premarket approval P000018/S016 · decided 2002-01-30
Approval details
- PMA number
- P000018
- Supplement
- S016
- Supplement type
- Real-Time Process
- Supplement reason
- Postapproval Study Protocol
- Trade name
- NOVOSTE BETA-CATH SYSTEM
- Generic name
- Intravascular radiation delivery system
- Applicant
- Best Vascular, Inc.
- Date received
- 2001-08-07
- Decision date
- 2002-01-30
- Days to decision
- 176 days
- Decision code
- APPR
- Product code
- MOU
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Norcross, GA
- 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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