PMA P160035S024

Device: EXCOR® Pediatric Ventricular Assist Device
Applicant: Berlin Heart, Inc.
PMA number: P160035
Supplement: S024
Product code: DSQ
Decision date: 2022-03-04
Generic name: Ventricular (assist) bypass
Approval order statement: Change to the post-conditioning aeration process following Ethylene Oxide sterilization and the addition of another aeration chamber.

Current openFDA PMA Record#

Device: EXCOR® Pediatric Ventricular Assist Device
Applicant: Berlin Heart, Inc.
PMA number: P160035
Supplement: S024
Product code: DSQ
Generic name: Ventricular (assist) bypass
Decision date: 2022-03-04
Decision code: APPR
Date received: 2021-11-08
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Change to the post-conditioning aeration process following Ethylene Oxide sterilization and the addition of another aeration chamber.