PMA P160035S021

Device: EXCOR Pediatric Ventricular Assist Device
Applicant: Berlin Heart, Inc.
PMA number: P160035
Supplement: S021
Product code: DSQ
Decision date: 2021-10-20
Generic name: Ventricular (assist) bypass
Approval order statement: changes to the test program in the software used to determine the roughness of sloping and curved surfaces of the titanium connectors and adapters of the connecting and extension sets for the EXCOR blood pumps

Current openFDA PMA Record#

Device: EXCOR Pediatric Ventricular Assist Device
Applicant: Berlin Heart, Inc.
PMA number: P160035
Supplement: S021
Product code: DSQ
Generic name: Ventricular (assist) bypass
Decision date: 2021-10-20
Decision code: OK30
Date received: 2021-09-21
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: changes to the test program in the software used to determine the roughness of sloping and curved surfaces of the titanium connectors and adapters of the connecting and extension sets for the EXCOR blood pumps