PMA P180051S006
- Device
- Organ Care System™ (OCS™) Heart
- Applicant
- TransMedics, Inc.
- PMA number
- P180051
- Supplement
- S006
- Product code
- QIK
- Decision date
- 2024-10-11
- Classification
- Cardiovascular
- Generic name
- Organ care system (OCS) heart system
- Approval order statement
- change in manufacturing process
Current openFDA PMA Record#
- Device
- Organ Care System™ (OCS™) Heart
- Applicant
- TransMedics, Inc.
- PMA number
- P180051
- Supplement
- S006
- Product code
- QIK
- Generic name
- Organ care system (OCS) heart system
- Decision date
- 2024-10-11
- Decision code
- OK30
- Date received
- 2024-09-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- change in manufacturing process