BETA-CATH(TM) SYSTEM
FDA premarket approval P000018/S003 · decided 2001-04-24
Approval details
- PMA number
- P000018
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Postapproval Study Protocol
- Trade name
- BETA-CATH(TM) SYSTEM
- Generic name
- Intravascular radiation delivery system
- Applicant
- Best Vascular, Inc.
- Date received
- 2000-12-19
- Decision date
- 2001-04-24
- Days to decision
- 126 days
- Decision code
- APPR
- Product code
- MOU
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Norcross, GA
- 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.
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