TALENT THORACIC STENT GRAFT SYSTEM
FDA premarket approval P070007/S003 · decided 2009-05-21
Approval details
- PMA number
- P070007
- Supplement
- S003
- Supplement type
- 135 Review Track For 30-Day Notice
- Trade name
- TALENT THORACIC STENT GRAFT SYSTEM
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Medtronic Vascular
- Date received
- 2008-08-18
- Decision date
- 2009-05-21
- Days to decision
- 276 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- APPROVAL FOR A MODIFICATION TO THE CURRENT MANUFACTURING PROCESS USED BY THE SUPPLIER OF STENT COMPONENTS FOR THE DEVICE.
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