TALENT OCCLUDER WITH OCCLUDER DELIVERY SYSTEM
FDA premarket approval P070027/S044 · decided 2016-04-22
Approval details
- PMA number
- P070027
- Supplement
- S044
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- TALENT OCCLUDER WITH OCCLUDER DELIVERY SYSTEM
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Medtronic Vascular
- Date received
- 2015-08-31
- Decision date
- 2016-04-22
- Days to decision
- 235 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- Approval for 1) a site change for inspection and packaging/shipping of delivery system components; 2) addition of a visual inspection process; and 3) change in a detergent for machining operations.
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