NOVOSTE (TM) BETA-CATH(TM) SYSTEM
FDA premarket approval P000018/S017 · decided 2001-09-26
Approval details
- PMA number
- P000018
- Supplement
- S017
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- NOVOSTE (TM) BETA-CATH(TM) SYSTEM
- Generic name
- Intravascular radiation delivery system
- Applicant
- Best Vascular, Inc.
- Date received
- 2001-08-27
- Decision date
- 2001-09-26
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- MOU
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Norcross, GA
- Statement
- ALTERNATE METHOD OF MANUFACTURE FOR THE DRYING OPERATION OF THE BETA-CATH(TM) DELIVERY CATHETER.
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