ACS RX COMET VP CORONARY DILATATION CATHETER (OTHER DILATATION CATHETERS)
FDA premarket approval P810046/S196 · decided 1999-01-22
Approval details
- PMA number
- P810046
- Supplement
- S196
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ACS RX COMET VP CORONARY DILATATION CATHETER (OTHER DILATATION CATHETERS)
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Applicant
- Advanced Cardiovascular Systems, Inc.
- Date received
- 1998-12-22
- Decision date
- 1999-01-22
- Days to decision
- 31 days
- Decision code
- APPR
- Product code
- LOX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Temecula, CA
- Statement
- Approval for the implementation of an additional quality control inspection to further ensure that hte balloon size designation on the proximal adaptor is correct fo rthe ACS RX Comet VP(TM) Coronary Dilatation Catheter and the other ACS Coronary Dilatation Catheters listed in the supplement.
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