ACX RX COMET VP CORONARY DILATATION CATHETER
FDA premarket approval P810046/S169 · decided 1997-02-04
Approval details
- PMA number
- P810046
- Supplement
- S169
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ACX RX COMET VP CORONARY DILATATION CATHETER
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Applicant
- Advanced Cardiovascular Systems, Inc.
- Date received
- 1996-10-07
- Decision date
- 1997-02-04
- Days to decision
- 120 days
- Decision code
- APPR
- Product code
- LOX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Temecula, CA
- Statement
- APPROVAL FOR THE ACS RX COMET VP(TM) CORONARY DILATATION CATHETER. THIS DEVICE IS INDICATED FOR BALLOON DILATATION OF THE STENOTIC PROTION OF A CORONARY ARTERY OR BYPASS GRAFT STENOSIS FOR HTE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION.
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