PMA P210006S002
- Device
- Thoraflex Hybrid
- 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
- PMA number
- P210006
- Supplement
- S002
- Product code
- QSK
- Decision date
- 2022-06-16
- Generic name
- Hybrid Stent Graft, Thoracic Aortic Lesion Treatment
Current openFDA PMA Record
- Device
- Thoraflex Hybrid
- Applicant
- Vascutek, Ltd.
- PMA number
- P210006
- Supplement
- S002
- Product code
- QSK
- Generic name
- Hybrid stent graft, thoracic aortic lesion treatment
- Decision date
- 2022-06-16
- Decision code
- OK30
- Date received
- 2022-05-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- 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.