Approval for the organ care system (ocs) heart system. This device is indicated for the preservation of donor-after-brain-death (dbd) hearts deemed unsuitable for procurement and transplantation at initial evaluation due to limitations of prolonged cold static cardioplegic preservation (e. G. , > 4 hours of cross-clamp time).
| Device | Organ Care System (OCS) Heart System |
| Generic Name | Organ Care System (ocs) Heart System |
| Applicant | TransMedics, Inc. |
| Date Received | 2018-12-26 |
| Decision Date | 2021-09-03 |
| PMA | P180051 |
| Supplement | S |
| Product Code | QIK |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | TransMedics, Inc. 200 Minuteman Road, Suite 302 andover, MA 01810 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P180051 | | Original Filing |
| S001 |
2021-11-08 |
Panel Track |
NIH GUDID Devices