NOVOSTE(TM) BETA-CATH(TM) SYSTEM
FDA premarket approval P000018/S011 · decided 2001-08-22
Approval details
- PMA number
- P000018
- Supplement
- S011
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- NOVOSTE(TM) BETA-CATH(TM) SYSTEM
- Generic name
- Intravascular radiation delivery system
- Applicant
- Best Vascular, Inc.
- Date received
- 2001-02-21
- Decision date
- 2001-08-22
- Days to decision
- 182 days
- Decision code
- APPR
- Product code
- MOU
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Norcross, GA
- Statement
- APPROVAL FOR MODIFICATIONS TO THE DESIGN OF THE PROXIMAL MARKER OF THE SOURCE TRAIN.
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