PMA P130021S083
- Device
- Evolut R, Pro and Pro+ Systems
- Applicant
- Medtronic, Inc.
- PMA number
- P130021
- Supplement
- S083
- Product code
- NPT
- Decision date
- 2020-12-08
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Approval order statement
- Approval for various labeling changes related to post implant dilatation
Current openFDA PMA Record#
- Device
- Evolut R, Pro and Pro+ Systems
- Applicant
- Medtronic, Inc.
- PMA number
- P130021
- Supplement
- S083
- Product code
- NPT
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Decision date
- 2020-12-08
- Decision code
- APPR
- Date received
- 2020-11-12
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for various labeling changes related to post implant dilatation