RX VOYAGER CORONARY DILATATION CATHETER
FDA premarket approval P810046/S217 · decided 2005-11-22
Approval details
- PMA number
- P810046
- Supplement
- S217
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- RX VOYAGER CORONARY DILATATION CATHETER
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Applicant
- Advanced Cardiovascular Systems, Inc.
- Date received
- 2004-11-01
- Decision date
- 2005-11-22
- Days to decision
- 386 days
- Decision code
- APPR
- Product code
- LOX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Temecula, CA
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT GUIDANT IRELAND, TIPPERY, IRELAND.
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