ACS TX 2000 VP CORONARY DILATATION CATHETER CAHTETERS
FDA premarket approval P810046/S181 · decided 1997-11-26
Approval details
- PMA number
- P810046
- Supplement
- S181
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ACS TX 2000 VP CORONARY DILATATION CATHETER CAHTETERS
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Applicant
- Advanced Cardiovascular Systems, Inc.
- Date received
- 1997-08-18
- Decision date
- 1997-11-26
- Days to decision
- 100 days
- Decision code
- APPR
- Product code
- LOX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Temecula, CA
- Statement
- Approval for the ACS Tx2000VP(TM) coronary dilatation catheter with additional balloon sizes 2.75, 3.25, and 3.75 x 15 mm and 20 mm.
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