PMA P200046S038
- Device
- Harmony™ Delivery Catheter System
- Applicant
- Medtronic, Inc.
- PMA number
- P200046
- Supplement
- S038
- Product code
- NPV
- Decision date
- 2025-04-07
- Classification
- Cardiovascular
- Generic name
- Pulmonary valve prosthesis percutaneously delivered
- Approval order statement
- the implementation of changes to the label printing system
Current openFDA PMA Record#
- Device
- Harmony™ Delivery Catheter System
- Applicant
- Medtronic, Inc.
- PMA number
- P200046
- Supplement
- S038
- Product code
- NPV
- Generic name
- Pulmonary valve prosthesis percutaneously delivered
- Decision date
- 2025-04-07
- Decision code
- OK30
- Date received
- 2025-03-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- the implementation of changes to the label printing system