PMA P970029

Device: CardioGenesis TMR System
Applicant: Cryolife, Inc.
PMA number: P970029
Supplement: S040
Product code: MNO
Decision date: 2022-09-01
Generic name: SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION
Approval order statement: Approval for the addition of chassis grounding resistance and chassis leakage current tests to the service manual for use after repair, maintenance, and installation activities.

Current openFDA PMA Record#

Device: CardioGenesis TMR System
Applicant: Cryolife, Inc.
PMA number: P970029
Supplement: S040
Product code: MNO
Generic name: SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION
Decision date: 2022-09-01
Decision code: APPR
Date received: 2022-08-04
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for the addition of chassis grounding resistance and chassis leakage current tests to the service manual for use after repair, maintenance, and installation activities.