POWERSAIL CORONARY DILATATION CATHETER
FDA premarket approval P810046/S229 · decided 2009-04-24
Approval details
- PMA number
- P810046
- Supplement
- S229
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- POWERSAIL CORONARY DILATATION CATHETER
- Generic name
- STENT, CORONARY
- Applicant
- Advanced Cardiovascular Systems, Inc.
- Date received
- 2009-04-01
- Decision date
- 2009-04-24
- Days to decision
- 23 days
- Decision code
- OK30
- Product code
- MAF
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Temecula, CA
- Statement
- ADDITION OF VISUAL INSPECTION OF THE DISTAL SHAFT AND THE ADDITION OF A VERIFICATION OF IN-PROCESS MEASURING EQUIPMENT.
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