NOVOSTE BETA-CATH SYSTEM
FDA premarket approval P000018/S006 · decided 2001-01-29
Approval details
- PMA number
- P000018
- Supplement
- S006
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- NOVOSTE BETA-CATH SYSTEM
- Generic name
- Intravascular radiation delivery system
- Applicant
- Best Vascular, Inc.
- Date received
- 2001-01-05
- Decision date
- 2001-01-29
- Days to decision
- 24 days
- Decision code
- OK30
- Product code
- MOU
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Norcross, GA
- Statement
- CHANGE IN THE INSERT MOLDING PROCESS PARAMETERS FOR A COMPONENT OF THE PROPRIETARY CONNECTOR (THE PUCK), WHICH IS MOLDED TO THE 3-LUMEN TUBING OF THE DELIVERY CATHETER.
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