NOVOSTE(TM) BETA-CATH(TM) SYSTEM
FDA premarket approval P000018/S019 · decided 2002-05-02
Approval details
- PMA number
- P000018
- Supplement
- S019
- Supplement type
- Normal 180 Day Track
- Trade name
- NOVOSTE(TM) BETA-CATH(TM) SYSTEM
- Generic name
- Intravascular radiation delivery system
- Applicant
- Best Vascular, Inc.
- Date received
- 2001-10-02
- Decision date
- 2002-05-02
- Days to decision
- 212 days
- Decision code
- APPR
- Product code
- MOU
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Norcross, GA
- Statement
- APPROVAL FOR THE NOVOSTE BETA-CATH XL DELIVERY CATHETER (TOTAL LENGTH 267 CM.) TO BE USED WITH THE 30 AND 40 MM NOVOSTE BETA-CATH SYSTEMS.
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