TALENT TAA STENT GRAFT DELIVERY SYSTEM
FDA premarket approval P070007/S018 · decided 2010-06-18
Approval details
- PMA number
- P070007
- Supplement
- S018
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- TALENT TAA STENT GRAFT DELIVERY SYSTEM
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Medtronic Vascular
- Date received
- 2010-05-05
- Decision date
- 2010-06-18
- Days to decision
- 44 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- APPROVAL FOR A STERILIZATION SITE LOCATED AT ISOTRON IRELAND LTD, OFFALY, IRELAND, AS AN ALTERNATIVE E-BEAM STERILIZATION SITE.
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