NOVOSTE BETA-CATH SYSTEM
FDA premarket approval P000018/S045 · decided 2011-11-04
Approval details
- PMA number
- P000018
- Supplement
- S045
- Supplement type
- 135 Review Track For 30-Day Notice
- Trade name
- NOVOSTE BETA-CATH SYSTEM
- Generic name
- Intravascular radiation delivery system
- Applicant
- Best Vascular, Inc.
- Date received
- 2011-06-20
- Decision date
- 2011-11-04
- Days to decision
- 137 days
- Decision code
- APPR
- Product code
- MOU
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Norcross, GA
- Statement
- APPROVAL FOR CHANGING LUBING SUPPLIERS.
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