NOVOSTE BETA-CATH SYSTEM
FDA premarket approval P000018/S046 · decided 2016-10-06
Approval details
- PMA number
- P000018
- Supplement
- S046
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- NOVOSTE BETA-CATH SYSTEM
- Generic name
- Intravascular radiation delivery system
- Applicant
- Best Vascular, Inc.
- Date received
- 2014-11-20
- Decision date
- 2016-10-06
- Days to decision
- 686 days
- Decision code
- APPR
- Product code
- MOU
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Norcross, GA
- Statement
- Approval to extend the service life of the PCBA and PIB components located in the Transfer Device to 26 months.
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