ACS RX GEMINI CORONARY DILATATION CATHETER
FDA premarket approval P810046/S197 · decided 1999-03-04
Approval details
- PMA number
- P810046
- Supplement
- S197
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ACS RX GEMINI CORONARY DILATATION CATHETER
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Applicant
- Advanced Cardiovascular Systems, Inc.
- Date received
- 1999-02-09
- Decision date
- 1999-03-04
- Days to decision
- 23 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 the balloon size designation on the proximal adaptor is correct for the ACS RX Gemini(TM) Coronary Dilatation Catheter.
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