ACS RX ESPRIT CORONARY DILATION CATHETER
FDA premarket approval P810046/S190 · decided 1998-07-30
Approval details
- PMA number
- P810046
- Supplement
- S190
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ACS RX ESPRIT CORONARY DILATION CATHETER
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Applicant
- Advanced Cardiovascular Systems, Inc.
- Date received
- 1998-05-21
- Decision date
- 1998-07-30
- Days to decision
- 70 days
- Decision code
- APPR
- Product code
- LOX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Temecula, CA
- Statement
- Approval for additional balloon sizes for the ACS Avenger(TM) Coronary dilatation Catheter (quarter sizes within the range of 2.25-3.75 mm for the currently marketed 15mm and 20mm balloon lengths and half sizes in the rang eof 2.5-4.0mm for a 25mm balloon length.
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