PMA P790007S051

Device: Hancock Modified Orifice (MO) Valved Conduit, Model 150
Applicant: Medtronic Heart Valves
PMA number: P790007
Supplement: S051
Product code: LWR
Decision date: 2017-08-09
Classification: Heart-valve, Non-allograft Tissue
Generic name: heart-valve, non-allograft tissue
Approval order statement: Implement additional test samples for solution chemistry and sterility as part of the routine monitoring and lot release performed for terminal liquid sterilization.

Current openFDA PMA Record#

Device: Hancock Modified Orifice (MO) Valved Conduit, Model 150
Applicant: Medtronic Heart Valves
PMA number: P790007
Supplement: S051
Product code: LWR
Generic name: heart-valve, non-allograft tissue
Decision date: 2017-08-09
Decision code: OK30
Date received: 2017-07-10
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Implement additional test samples for solution chemistry and sterility as part of the routine monitoring and lot release performed for terminal liquid sterilization.