PMA P100047S066

Device: HEARTWARE VENTRICULAR ASSIST SYSTEM
Applicant: Medtronic
PMA number: P100047
Supplement: S066
Product code: DSQ
Decision date: 2015-12-10
Classification: Ventricular (assist) Bypass
Generic name: Ventricular (assist) bypass
Approval order statement: IMPLEMENTATION OF A CONNECTOR ASSEMBLY FIXTURE, CONNECTOR GLUING FIXTURE, ADDITIONAL INSPECTIONS DURING THE MANUFACTURING PROCESS AND TO MOVE THE CONTINUITY TEST TO FURTHER IN THE MANUFACTURING PROCESS.

Current openFDA PMA Record#

Device: HEARTWARE VENTRICULAR ASSIST SYSTEM
Applicant: Medtronic
PMA number: P100047
Supplement: S066
Product code: DSQ
Generic name: Ventricular (assist) bypass
Decision date: 2015-12-10
Decision code: OK30
Date received: 2015-10-19
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: IMPLEMENTATION OF A CONNECTOR ASSEMBLY FIXTURE, CONNECTOR GLUING FIXTURE, ADDITIONAL INSPECTIONS DURING THE MANUFACTURING PROCESS AND TO MOVE THE CONTINUITY TEST TO FURTHER IN THE MANUFACTURING PROCESS.