NOVOSTE BETA-CATH SYSTEM
FDA premarket approval P000018/S008 · decided 2001-10-26
Approval details
- PMA number
- P000018
- Supplement
- S008
- Supplement type
- Real-Time Process
- 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
- 2001-02-02
- Decision date
- 2001-10-26
- Days to decision
- 266 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 STERILE BAG AND FLUID COLLECTION BAG PROVIDED IN THE PROCEDURE ACCESSORY PACK.
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