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MEDTRONIC(R) HALL PROSTHETIC HEART VALVE

FDA premarket approval P790018/S007 · decided 1985-09-24

Approval details

PMA number
P790018
Supplement
S007
Trade name
MEDTRONIC(R) HALL PROSTHETIC HEART VALVE
Generic name
HEART-VALVE, MECHANICAL
Applicant
Medtronic Cardiac Surgery
Date received
1984-02-29
Decision date
1985-09-24
Days to decision
573 days
Decision code
APPR
Product code
LWQ
Advisory committee
Cardiovascular
Expedited review
No
Location
Minneapolis, MN

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510(k) clearances by this applicant

RecordFirmDate
MVR™ Venous Reservoir Bag 800 mL; MVR™ Venous Reservoir Bag 1600 mL; MVR™ Venous Reservoir Bag with Cortiva™ BioActive Surface 800 mL; MVR™ Venous Reservoir Bag with Cortiva™ BioActive Surface 1600 mL (K241053)Medtronic Cardiac Surgery2024-05-15