TX-2000
FDA premarket approval P810046/S173 · decided 1997-04-21
Approval details
- PMA number
- P810046
- Supplement
- S173
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- TX-2000
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Applicant
- Advanced Cardiovascular Systems, Inc.
- Date received
- 1997-01-16
- Decision date
- 1997-04-21
- Days to decision
- 95 days
- Decision code
- APPR
- Product code
- LOX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Temecula, CA
- Statement
- APPROVAL FOR THE ACS TX2000(TM) CORONARY DILATATION CATHETER WITH NEW BALLOON LENGTHS (15 MM AND 40 MM), ADDITIONAL BALLOON DIAMETERS FOR THE 20 MM AND 30 MM BALLOON LENGTHS, AND REVISED LABELING.
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