PMA P130021S062
- Device
- CoreValve Evolut R System and CoreValve Evolut PRO System
- Applicant
- Medtronic, Inc.
- PMA number
- P130021
- Supplement
- S062
- Product code
- NPT
- Decision date
- 2019-08-23
- Classification
- Aortic Valve, Prosthesis, Percutaneously Delivered
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Approval order statement
- Reduce the number of units required to be tested for routine Bacterial Endotoxin Testing (BET) for the EnVeo R and EnVeo PRO Delivery Catheter System and Loading System.
Current openFDA PMA Record#
- Device
- CoreValve Evolut R System and CoreValve Evolut PRO System
- Applicant
- Medtronic, Inc.
- PMA number
- P130021
- Supplement
- S062
- Product code
- NPT
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Decision date
- 2019-08-23
- Decision code
- OK30
- Date received
- 2019-08-22
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Reduce the number of units required to be tested for routine Bacterial Endotoxin Testing (BET) for the EnVeo R and EnVeo PRO Delivery Catheter System and Loading System.