ACS RX/OTW SOLARIS CORONARY DILATATION CATHETER
FDA premarket approval P810046/S200 · decided 2000-02-16
Approval details
- PMA number
- P810046
- Supplement
- S200
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ACS RX/OTW SOLARIS CORONARY DILATATION CATHETER
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Applicant
- Advanced Cardiovascular Systems, Inc.
- Date received
- 2000-01-20
- Decision date
- 2000-02-16
- Days to decision
- 27 days
- Decision code
- APPR
- Product code
- LOX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Temecula, CA
- Statement
- A revision to the Instructions for Use booklet for ACS RX SOLARIS and ACS OTW SOLARIS Coronary Dilatation Catheters to include the addition fo the ACS Multi-Link Tristar Stent to the sections pertaining to post-implant stent dilatation.
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