PMA P160035S057

Device: EXCOR Pediatric Ventricular Assist Device
Applicant: Berlin Heart, Inc.
PMA number: P160035
Supplement: S057
Product code: DSQ
Decision date: 2026-10-01
Classification: Cardiovascular
Generic name: Ventricular (assist) bypass
Approval order statement: Approval for the implementation of dynamic viscosity measurement with specification limits for silicone coating solution used in the manufacture of EXCOR® cannulae and connecting/extension sets

Current openFDA PMA Record#

Device: EXCOR Pediatric Ventricular Assist Device
Applicant: Berlin Heart, Inc.
PMA number: P160035
Supplement: S057
Product code: DSQ
Generic name: Ventricular (assist) bypass
Decision date: 2026-10-01
Decision code: APPR
Date received: 2026-03-03
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for the implementation of dynamic viscosity measurement with specification limits for silicone coating solution used in the manufacture of EXCOR® cannulae and connecting/extension sets