NOVOSTE BETA-CATH SYSTEM
FDA premarket approval P000018/S009 · decided 2001-10-26
Approval details
- PMA number
- P000018
- Supplement
- S009
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Other
- Trade name
- NOVOSTE BETA-CATH SYSTEM
- Generic name
- Intravascular radiation delivery system
- Applicant
- Best Vascular, Inc.
- Date received
- 2001-02-12
- Decision date
- 2001-10-26
- Days to decision
- 256 days
- Decision code
- APPR
- Product code
- MOU
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Norcross, GA
- Statement
- APPROVAL FOR THE REVISED SOURCE SEED SPECIFICATION (2.7 - 40 MCI) FOR THE BETA-CATH SYSTEM.
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