- Device
- Harmony™ Delivery Catheter System (HARMONY-DCS)
- Applicant
- Medtronic, Inc.
- PMA number
- P200046
- Supplement
- S046
- Product code
- NPV
- Generic name
- Pulmonary valve prosthesis percutaneously delivered
- Decision date
- 2026-02-11
- Decision code
- OK30
- Date received
- 2026-01-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- an additional, alternative external Process Challenge Device (ePCD) for routine monitoring of the ethylene-oxide-sterilization process and reduction the incubation time of the proposed ePCD from the standard 7 days to 4 days