PMA P200046S011
- Device
- Harmony™ Transcatheter Pulmonary Valve
- Applicant
- Medtronic, Inc.
- PMA number
- P200046
- Supplement
- S011
- Product code
- NPV
- Decision date
- 2022-07-27
- Generic name
- Pulmonary 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
- Harmony™ Transcatheter Pulmonary Valve
- Applicant
- Medtronic, Inc.
- PMA number
- P200046
- Supplement
- S011
- Product code
- NPV
- Generic name
- Pulmonary valve prosthesis percutaneously delivered
- Decision date
- 2022-07-27
- Decision code
- OK30
- Date received
- 2022-07-26
- 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.