BETA-CATH SYSTEM
FDA premarket approval P000018/S044 · decided 2011-02-23
Approval details
- PMA number
- P000018
- Supplement
- S044
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Trade name
- BETA-CATH SYSTEM
- Generic name
- Intravascular radiation delivery system
- Applicant
- Best Vascular, Inc.
- Date received
- 2010-09-24
- Decision date
- 2011-02-23
- Days to decision
- 152 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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