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PMA P100047S167

Device
HeartWare Ventricular Assist System
Applicant
Medtronic
PMA number
P100047
Supplement
S167
Product code
DSQ
Decision date
2020-07-15
Generic name
Ventricular (assist) bypass
Approval order statement
Replace the existing recording system for monitoring parameters in the manufacturing areas and water system with an automated environmental monitoring application at the Miami Lakes facility.

Current openFDA PMA Record#

Device
HeartWare Ventricular Assist System
Applicant
Medtronic
PMA number
P100047
Supplement
S167
Product code
DSQ
Generic name
Ventricular (assist) bypass
Decision date
2020-07-15
Decision code
OK30
Date received
2020-06-19
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Replace the existing recording system for monitoring parameters in the manufacturing areas and water system with an automated environmental monitoring application at the Miami Lakes facility.