TALENT ABDOMINAL STENT GRAFT SYSTEM
FDA premarket approval P070027/S027 · decided 2011-04-12
Approval details
- PMA number
- P070027
- Supplement
- S027
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- TALENT ABDOMINAL STENT GRAFT SYSTEM
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Medtronic Vascular
- Date received
- 2010-12-10
- Decision date
- 2011-04-12
- Days to decision
- 123 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- APPROVAL TO EXTEND THE SCOPE OF THE RECEIVING AND MANUFACTURING ACTIVITIES CONDUCTED AT A THIRD PARTY STORAGE LOCATION.
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