This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
| Device | OCS Heart System |
| Generic Name | Organ Care System (ocs) Heart System |
| Applicant | TransMedics, Inc.200 Minuteman Road, Suite 302andover, MA 01810 PMA NumberP180051 Supplement NumberS001 Date Received11/08/2021 Decision Date04/27/2022 Product Code QIK Advisory Committee Cardiovascular Clinical TrialsNCT03831048 Supplement Typepanel Track Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No |
| Date Received | 2021-11-08 |
| Decision Date | 2022-04-27 |
| PMA | P180051 |
| Supplement | S001 |
| Product Code | QIK |
| Advisory Committee | Cardiovascular |
| Supplement Type | Panel Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | TransMedics, Inc. 200 Minuteman Road, Suite 302 andover, MA 01810 PMA NumberP180051 Supplement NumberS001 Date Received11/08/2021 Decision Date04/27/2022 Product Code QIK Advisory Committee Cardiovascular Clinical TrialsNCT03831048 Supplement Typepanel Track Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No Combination ProductNo Approval Order Statement Approval For The Organ Care System (OCS) Heart System For Expanding The Indication To Include Donation-after-circulatory-death (DCD) Donor Hearts. The Device Is Indicated For The Preservation Of Donation-after-brain-death (DBD) Hearts Initially 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). The OCS Heart System Is Also Indicated For The Ex Vivo Reanimation, Functional Monitoring, And Beating-heart Preservation Of DCD Hearts. |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P180051 | Original Filing | |
| S001 | 2021-11-08 | Panel Track |
| Device ID | PMA | Supp |
|---|---|---|
| B00953975 | P180051 | 000 |
| B00913600 | P180051 | 000 |
| B00918043 | P180051 | 000 |
| B00924420 | P180051 | 000 |
| B00925721 | P180051 | 000 |
| B00925741 | P180051 | 000 |
| B00925751 | P180051 | 000 |
| B00926340 | P180051 | 000 |
| B00936363 | P180051 | 000 |
| B00936463 | P180051 | 000 |
| B00943661 | P180051 | 000 |
| B00948225 | P180051 | 000 |
| B00948913 | P180051 | 000 |
| B00949290 | P180051 | 000 |
| B00913390 | P180051 | 000 |