PMA P130021S067
- Device
- EnVeo Rand EnVeo PRO Delivery Catheter System of the CoreValve
- Applicant
- Medtronic, Inc.
- PMA number
- P130021
- Supplement
- S067
- Product code
- NPT
- Decision date
- 2019-11-13
- Classification
- Aortic Valve, Prosthesis, Percutaneously Delivered
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Approval order statement
- Packaging and labeling rework for EnVeo R and EnVeo PRO Delivery Catheter Systems (DCS) to be performed at the Brooklyn Park North facility.
Current openFDA PMA Record#
- Device
- EnVeo Rand EnVeo PRO Delivery Catheter System of the CoreValve
- Applicant
- Medtronic, Inc.
- PMA number
- P130021
- Supplement
- S067
- Product code
- NPT
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Decision date
- 2019-11-13
- Decision code
- OK30
- Date received
- 2019-10-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Packaging and labeling rework for EnVeo R and EnVeo PRO Delivery Catheter Systems (DCS) to be performed at the Brooklyn Park North facility.