VOYAGER NC CORONARY DILATATION CATHETER
FDA premarket approval P810046/S232 · decided 2010-02-04
Approval details
- PMA number
- P810046
- Supplement
- S232
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VOYAGER NC CORONARY DILATATION CATHETER
- Generic name
- STENT, CORONARY
- Applicant
- Advanced Cardiovascular Systems, Inc.
- Date received
- 2009-12-09
- Decision date
- 2010-02-04
- Days to decision
- 57 days
- Decision code
- APPR
- Product code
- MAF
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Temecula, CA
- Statement
- APPROVAL FOR A LINE EXTENSION FOR A 1.5MM DIAMETER SIZE OF THE VOYAGER NC CORONARY DILATION CATHETER.
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