Thoraflex Hybrid

FDA Premarket Approval P210006 S002

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

DeviceThoraflex Hybrid
Generic NameHybrid Stent Graft, Thoracic Aortic Lesion Treatment
ApplicantVascutek Ltd.newmains Avenueinchinnan PA4 9 PMA NumberP210006 Supplement NumberS002 Date Received05/19/2022 Decision Date06/16/2022 Product Code QSK  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-05-19
Decision Date2022-06-16
PMAP210006
SupplementS002
Product CodeQSK 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressVascutek Ltd.
newmains Avenue
inchinnan PA4 9 PMA NumberP210006 Supplement NumberS002 Date Received05/19/2022 Decision Date06/16/2022 Product Code QSK  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement  
implementation Of A New In-process Inspection Step, New Equipment For Aeration And New Colorant Resin For A Component Of The Delivery System Of The Thoraflex Hybrid Device

Supplemental Filings

Supplement NumberDateSupplement Type
P210006Original Filing
S002 2022-05-19 30-day Notice
S001

NIH GUDID Devices

Device IDPMASupp
05037881027081 P210006 000
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05037881026800 P210006 000
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05037881026954 P210006 000
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05037881026626 P210006 000

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