POWERSAIL/HIGHSAIL CORONARY DILATATION CATHETER
FDA premarket approval P810046/S210 · decided 2002-02-15
Approval details
- PMA number
- P810046
- Supplement
- S210
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- POWERSAIL/HIGHSAIL CORONARY DILATATION CATHETER
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Applicant
- Advanced Cardiovascular Systems, Inc.
- Date received
- 2001-11-13
- Decision date
- 2002-02-15
- Days to decision
- 94 days
- Decision code
- APPR
- Product code
- LOX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Temecula, CA
- Statement
- APPROVAL FOR MODIFICATIONS IN MANUFACTURING PROCESS OF THE POWERSAIL AND HIGHSAIL PTCA CATHETERS.
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