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PMA P150036S048

Device
EDWARDS INTUITY Elite Valve
Applicant
Edwards Lifesciences, LLC
Product code
LWR
Decision date
2020-04-10
Generic name
heart-valve, non-allograft tissue
Approval order statement
Approval for a manufacturing site located at Edwards Lifesciences (Singapore) Pte. Ltd, 35 Changi North Crescent, Singapore 499641 SG, to receive and process bovine pericardial tissue sacs into treated tissue heart valve leaflets.

Current openFDA PMA Record#

Device
EDWARDS INTUITY Elite Valve
Applicant
Edwards Lifesciences, LLC
PMA number
P150036
Supplement
S048
Product code
LWR
Generic name
heart-valve, non-allograft tissue
Decision date
2020-04-10
Decision code
APPR
Date received
2019-11-18
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Approval for a manufacturing site located at Edwards Lifesciences (Singapore) Pte. Ltd, 35 Changi North Crescent, Singapore 499641 SG, to receive and process bovine pericardial tissue sacs into treated tissue heart valve leaflets.