FDA.reportPublic FDA data

PMA P100047S162

Device
HeartWare Ventricular Assist System
Applicant
Medtronic
PMA number
P100047
Supplement
S162
Product code
DSQ
Decision date
2020-06-03
Generic name
Ventricular (assist) bypass
Approval order statement
Changes to implement a new Multipart Fixture, Software Program, and a Controller Burn-in Data Verification Spreadsheet at Receiving Inspection of the HVAD System as part of a Corrective and Preventive Action (CAPA).

Current openFDA PMA Record#

Device
HeartWare Ventricular Assist System
Applicant
Medtronic
PMA number
P100047
Supplement
S162
Product code
DSQ
Generic name
Ventricular (assist) bypass
Decision date
2020-06-03
Decision code
OK30
Date received
2020-05-07
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Changes to implement a new Multipart Fixture, Software Program, and a Controller Burn-in Data Verification Spreadsheet at Receiving Inspection of the HVAD System as part of a Corrective and Preventive Action (CAPA).