CoreValve Evolut R System, CoreValve Evolut R XL System and CoreValve Evolut PRO System
FDA premarket approval P130021/S052 · decided 2018-08-12
Approval details
- PMA number
- P130021
- Supplement
- S052
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CoreValve Evolut R System, CoreValve Evolut R XL System and CoreValve Evolut PRO System
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Applicant
- Medtronic, Inc.
- Date received
- 2018-08-10
- Decision date
- 2018-08-12
- Days to decision
- 2 days
- Decision code
- OK30
- Product code
- NPT
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Miinneapolis, MN
- Statement
- Update the in-process sampling requirements for receiving inspection for the Tip Guide Tube and Locking Collar components of the EnVeo Pro Loading System.
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510(k) clearances by this applicant
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| Concerto Versa™ Detachable Coil (K253511) | Medtronic, Inc. | 2026-01-14 |
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