Talent Occluder
FDA premarket approval P100021/S085 · decided 2020-10-30
Approval details
- PMA number
- P100021
- Supplement
- S085
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Talent Occluder
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Medtronic Vascular
- Date received
- 2020-10-26
- Decision date
- 2020-10-30
- Days to decision
- 4 days
- Decision code
- OK30
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- Changes to the acceptance criteria for the temperature probes during product parameter profile studies conducted during requalification of the sterilization cycle.
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