ACS OTW SOLARIS CORONARY DILATATION CATHETER
FDA premarket approval P810046/S195 · decided 1999-05-19
Approval details
- PMA number
- P810046
- Supplement
- S195
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ACS OTW SOLARIS CORONARY DILATATION CATHETER
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Applicant
- Advanced Cardiovascular Systems, Inc.
- Date received
- 1998-12-21
- Decision date
- 1999-05-19
- Days to decision
- 149 days
- Decision code
- APPR
- Product code
- LOX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Temecula, CA
- Statement
- Approval for a new catheter model.
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