Evolut PRO+ Sysstem
FDA premarket approval P130021/S059 · decided 2019-09-19
Approval details
- PMA number
- P130021
- Supplement
- S059
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Evolut PRO+ Sysstem
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Applicant
- Medtronic, Inc.
- Date received
- 2019-05-13
- Decision date
- 2019-09-19
- Days to decision
- 129 days
- Decision code
- APPR
- Product code
- NPT
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Miinneapolis, MN
- Statement
- Approval for various modifications to the CoreValve Evolut PRO System. The device, as modified, will be marketed under the trade name Evolut PRO+ System.
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510(k) clearances by this applicant
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