PMA P180051S001

Device: OCS Heart System
Applicant: TransMedics, Inc.
PMA number: P180051
Supplement: S001
Product code: QIK
Decision date: 2022-04-27
Generic name: Organ care system (OCS) heart system
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.

Current openFDA PMA Record#

Device: OCS Heart System
Applicant: TransMedics, Inc.
PMA number: P180051
Supplement: S001
Product code: QIK
Generic name: Organ care system (OCS) heart system
Decision date: 2022-04-27
Decision code: APPR
Date received: 2021-11-08
Supplement type: Panel Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
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.