VOYAGER NC CORONARY DILATATION CATHETER
FDA premarket approval P810046/S238 · decided 2010-05-13
Approval details
- PMA number
- P810046
- Supplement
- S238
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- VOYAGER NC CORONARY DILATATION CATHETER
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Applicant
- Advanced Cardiovascular Systems, Inc.
- Date received
- 2010-04-14
- Decision date
- 2010-05-13
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- LOX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Temecula, CA
- Statement
- CHANGE IN THE EXTRUSION PROCESS FOR THE TUBING USED TO MANUFACTURE THE VOYAGER® NC CORONARY DILATATION CATHETER¿S 3.50 MM THROUGH 5.00 MM BALLOONS.
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