PMA P180051S009
- Device
- Organ Care System™ (OCS™) Heart
- Applicant
- TransMedics, Inc.
- PMA number
- P180051
- Supplement
- S009
- Product code
- QIK
- Decision date
- 2025-12-16
- Classification
- Cardiovascular
- Generic name
- Organ care system (OCS) heart system
- Approval order statement
- approval for a change in the pressure test condition in the inline leak test performed during assembly.
Current openFDA PMA Record#
- Device
- Organ Care System™ (OCS™) Heart
- Applicant
- TransMedics, Inc.
- PMA number
- P180051
- Supplement
- S009
- Product code
- QIK
- Generic name
- Organ care system (OCS) heart system
- Decision date
- 2025-12-16
- Decision code
- APPR
- Date received
- 2025-11-25
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval for a change in the pressure test condition in the inline leak test performed during assembly.