TALENT CAPTIVIA STENT GRAFT SYSTEM
FDA premarket approval P070007/S034 · decided 2012-03-05
Approval details
- PMA number
- P070007
- Supplement
- S034
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- TALENT CAPTIVIA STENT GRAFT SYSTEM
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Medtronic Vascular
- Date received
- 2012-02-07
- Decision date
- 2012-03-05
- Days to decision
- 27 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- APPROVAL FOR LABELING CHANGES AND A CHANGE IN THE GRAFT LOADING PROCESS.
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