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PMA P990046S056

Device
Open Pivot Heart Valves and Open Pivot Aortic Valved Graft
Applicant
Medtronic Ats Medical, Inc.
PMA number
P990046
Supplement
S056
Product code
LWQ
Decision date
2020-03-20
Generic name
HEART-VALVE, MECHANICAL
Approval order statement
Modification to the manufacturing in-process inspection acceptance criteria for percent silicon weight of pyrolytic carbon coated orifices and leaflets.

Current openFDA PMA Record#

Device
Open Pivot Heart Valves and Open Pivot Aortic Valved Graft
Applicant
Medtronic Ats Medical, Inc.
PMA number
P990046
Supplement
S056
Product code
LWQ
Generic name
HEART-VALVE, MECHANICAL
Decision date
2020-03-20
Decision code
OK30
Date received
2020-02-20
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Modification to the manufacturing in-process inspection acceptance criteria for percent silicon weight of pyrolytic carbon coated orifices and leaflets.