NOVOSTE BETA-CATH 3.5F SYSTEM
FDA premarket approval P000018/S040 · decided 2004-06-10
Approval details
- PMA number
- P000018
- Supplement
- S040
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- NOVOSTE BETA-CATH 3.5F SYSTEM
- Generic name
- Intravascular radiation delivery system
- Applicant
- Best Vascular, Inc.
- Date received
- 2003-12-16
- Decision date
- 2004-06-10
- Days to decision
- 177 days
- Decision code
- APPR
- Product code
- MOU
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Norcross, GA
- Statement
- APPROVAL FOR THE BETA-RAIL 3.5F DELIVERY CATHETER WITH DISTAL IMPROVEMENTS, AND A CHANGE IN THE PROCEDURE ACCESSORY PACK.
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