HIGHSAIL CORONARY DILATATION CATHETERS
FDA premarket approval P810046/S212 · decided 2002-05-10
Approval details
- PMA number
- P810046
- Supplement
- S212
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- HIGHSAIL CORONARY DILATATION CATHETERS
- Generic name
- CATHETER, FLOW DIRECTED
- Applicant
- Advanced Cardiovascular Systems, Inc.
- Date received
- 2002-03-11
- Decision date
- 2002-05-10
- Days to decision
- 60 days
- Decision code
- APPR
- Product code
- DYG
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Temecula, CA
- Statement
- APPROVAL TO MODIFY THE PACKAGING BY ELIMINATING THE FLUSHING TOOL AND REPLACING THE DISPENSER TUBING COIL.
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