VOYAGER RX CORONARY DILATATION CATHETER
FDA premarket approval P810046/S221 · decided 2006-12-11
Approval details
- PMA number
- P810046
- Supplement
- S221
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- VOYAGER RX CORONARY DILATATION CATHETER
- Generic name
- STENT, CORONARY
- Applicant
- Advanced Cardiovascular Systems, Inc.
- Date received
- 2006-11-13
- Decision date
- 2006-12-11
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- MAF
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Temecula, CA
- Statement
- APPROVAL FOR AN ALTERNATE STERILIZATION SITE LOCATED AT ISOTRON IRELAND, LTD, OFFALY, IRELAND.
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