PMA P130021S093
- Device
- EnVeo R, EnVeo PRO and Evolut PRO+ Delivery Catheter Systems
- Applicant
- Medtronic, Inc.
- PMA number
- P130021
- Supplement
- S093
- Product code
- NPT
- Decision date
- 2021-04-29
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Approval order statement
- Modification of the patency inspection on the outer member sub-assembly of the delivery catheter system.
Current openFDA PMA Record#
- Device
- EnVeo R, EnVeo PRO and Evolut PRO+ Delivery Catheter Systems
- Applicant
- Medtronic, Inc.
- PMA number
- P130021
- Supplement
- S093
- Product code
- NPT
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Decision date
- 2021-04-29
- Decision code
- OK30
- Date received
- 2021-04-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modification of the patency inspection on the outer member sub-assembly of the delivery catheter system.