BETA-CATH SYSTEM
FDA premarket approval P000018/S043 · decided 2008-11-19
Approval details
- PMA number
- P000018
- Supplement
- S043
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- BETA-CATH SYSTEM
- Generic name
- Intravascular radiation delivery system
- Applicant
- Best Vascular, Inc.
- Date received
- 2006-11-28
- Decision date
- 2008-11-19
- Days to decision
- 722 days
- Decision code
- APPR
- Product code
- MOU
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Norcross, GA
- Statement
- APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
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