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

• Device: Thoraflex Hybrid
• Generic Name: Hybrid Stent Graft, Thoracic Aortic Lesion Treatment
• Applicant: Vascutek 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 Received: 2022-05-19
• Decision Date: 2022-06-16
• PMA: P210006
• Supplement: S002
• Product Code: QSK
• Advisory Committee: Cardiovascular
• Supplement Type: 30-day Notice
• Supplement Reason: Process Change - Manufacturer/sterilizer/packager/supplier
• Expedited Review: No
• Combination Product: No
• Applicant Address: Vascutek 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 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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