PMA P200046S039
- Device
- Harmony Transcatheter Pulmonic Valve (TPV) System
- Applicant
- Medtronic, Inc.
- PMA number
- P200046
- Supplement
- S039
- Product code
- NPV
- Decision date
- 2025-04-07
- Classification
- Cardiovascular
- Generic name
- Pulmonary valve prosthesis percutaneously delivered
- Approval order statement
- reducing the sample size requirements for in-process pouch tensile testing
Current openFDA PMA Record#
- Device
- Harmony Transcatheter Pulmonic Valve (TPV) System
- Applicant
- Medtronic, Inc.
- PMA number
- P200046
- Supplement
- S039
- Product code
- NPV
- Generic name
- Pulmonary valve prosthesis percutaneously delivered
- Decision date
- 2025-04-07
- Decision code
- OK30
- Date received
- 2025-03-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- reducing the sample size requirements for in-process pouch tensile testing