PMA P130021S068
- Device
- CoreValve Evolut R System, CoreValve Evolut PRO System, and CoreValve Evolut PRO + System
- Applicant
- Medtronic, Inc.
- PMA number
- P130021
- Supplement
- S068
- Product code
- NPT
- Decision date
- 2019-11-07
- Classification
- Aortic Valve, Prosthesis, Percutaneously Delivered
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Approval order statement
- Increase in the timeframe for receipt of porcine pericardial tissue from abattoirs and initiation of tissue fixation.
Current openFDA PMA Record#
- Device
- CoreValve Evolut R System, CoreValve Evolut PRO System, and CoreValve Evolut PRO + System
- Applicant
- Medtronic, Inc.
- PMA number
- P130021
- Supplement
- S068
- Product code
- NPT
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Decision date
- 2019-11-07
- Decision code
- OK30
- Date received
- 2019-11-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Increase in the timeframe for receipt of porcine pericardial tissue from abattoirs and initiation of tissue fixation.