ACS TX2000 VP CORONARY DILITATION CATHETER
FDA premarket approval P810046/S172 · decided 1997-04-07
Approval details
- PMA number
- P810046
- Supplement
- S172
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ACS TX2000 VP CORONARY DILITATION CATHETER
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Applicant
- Advanced Cardiovascular Systems, Inc.
- Date received
- 1996-12-23
- Decision date
- 1997-04-07
- Days to decision
- 105 days
- Decision code
- APPR
- Product code
- LOX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Temecula, CA
- Statement
- APPROVAL FOR THE ACS TX2000 VP(TM) CORONARY DILATATION CATHETER. THIS CATHETER IS INDICATED FOR BALLOON DILATATION OF THE STENOTIC PORTION OF A CORONARY ARTERY OR BYPASS GRAFT STENOSIS FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION
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