PMA P210006S003
- Device
- Thoraflex™ Hybrid
- 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
- PMA number
- P210006
- Supplement
- S003
- Product code
- QSK
- Decision date
- 2022-09-29
- Generic name
- Hybrid Stent Graft, Thoracic Aortic Lesion Treatment
Current openFDA PMA Record
- Device
- Thoraflex Hybrid
- Applicant
- Vascutek, Ltd.
- PMA number
- P210006
- Supplement
- S003
- Product code
- QSK
- Generic name
- Hybrid stent graft, thoracic aortic lesion treatment
- Decision date
- 2022-09-29
- Decision code
- APPR
- Date received
- 2022-07-01
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for an increase in the labeled shelf life for the Thoraflex Hybrid device from 2 years to 55 months.