Thoraflex™ Hybrid

FDA Premarket Approval P210006 S003

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

• Device: Thoraflex™ Hybrid
• Generic Name: Hybrid Stent Graft, Thoracic Aortic Lesion Treatment
• Applicant: Vascutek Ltd.newmains Avenueinchinnan PA4 9 PMA NumberP210006 Supplement NumberS003 Date Received07/01/2022 Decision Date09/29/2022 Product Code QSK Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
• Date Received: 2022-07-01
• Decision Date: 2022-09-29
• PMA: P210006
• Supplement: S003
• Product Code: QSK
• Advisory Committee: Cardiovascular
• Supplement Type: Real-time Process
• Supplement Reason: Labeling Change - Indications/instructions/shelf Life/tradename
• Expedited Review: No
• Combination Product: No
• Applicant Address: Vascutek Ltd.; newmains Avenue; inchinnan PA4 9 PMA NumberP210006 Supplement NumberS003 Date Received07/01/2022 Decision Date09/29/2022 Product Code QSK Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No Combination ProductNo Approval Order Statement ; approval For An Increase In The Labeled Shelf Life For The Thoraflex Hybrid Device From 2 Years To 55 Months.

Supplemental Filings

Supplement Number	Date	Supplement Type
P210006		Original Filing
S003	2022-07-01	Real-time Process
S002	2022-05-19	30-day Notice
S001

NIH GUDID Devices

Device ID	PMA	Supp
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