TALENT THORACIC STENT GRAFT SYSTEM
FDA premarket approval P070007/S027 · decided 2011-02-07
Approval details
- PMA number
- P070007
- Supplement
- S027
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- TALENT THORACIC STENT GRAFT SYSTEM
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Medtronic Vascular
- Date received
- 2011-01-12
- Decision date
- 2011-02-07
- Days to decision
- 26 days
- Decision code
- OK30
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- CHANGE TO SAMPLE NUMBERS FOR ENDOTOXIN TESTING AND A LOT DEFINITION CHANGE.
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