POWERSAIL/HIGHSAIL CORONARY DILATION CATHETERS
FDA premarket approval P810046/S211 · decided 2002-02-22
Approval details
- PMA number
- P810046
- Supplement
- S211
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- POWERSAIL/HIGHSAIL CORONARY DILATION CATHETERS
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Applicant
- Advanced Cardiovascular Systems, Inc.
- Date received
- 2001-12-26
- Decision date
- 2002-02-22
- Days to decision
- 58 days
- Decision code
- APPR
- Product code
- LOX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Temecula, CA
- Statement
- APPROVAL FOR A SINGLE PROCESS CHANGE CONCERNING THE TEMPERATURE FOR THE ACCELERATING AGING PROTOCOL FOR THE SHELF-LIFE TESTING OF THE POWERSAIL AND HIGHSAIL CORONARY DILATATION CATHETERS.
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