VOYAGER NC CORONARY DILATATION CATHETER
FDA premarket approval P810046/S237 · decided 2010-06-01
Approval details
- PMA number
- P810046
- Supplement
- S237
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VOYAGER NC CORONARY DILATATION CATHETER
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Applicant
- Advanced Cardiovascular Systems, Inc.
- Date received
- 2010-04-02
- Decision date
- 2010-06-01
- Days to decision
- 60 days
- Decision code
- APPR
- Product code
- LOX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Temecula, CA
- Statement
- APPROVAL FOR A CHANGE IN THE IN-PROCESS EXTRUDED BALLOON TUBING OUTER DIAMETER.
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