PMA P210006S012
- Device
- Thoraflex Hybrid
- Applicant
- Vascutek, Ltd.
- PMA number
- P210006
- Supplement
- S012
- Product code
- QSK
- Decision date
- 2025-04-09
- Classification
- Cardiovascular
- Generic name
- Hybrid stent graft, thoracic aortic lesion treatment
- Approval order statement
- changes to the bioburden and cleanroom monitoring processes and addition of a new manufacturing equipment for the Thoraflex Hybrid
Current openFDA PMA Record#
- Device
- Thoraflex Hybrid
- Applicant
- Vascutek, Ltd.
- PMA number
- P210006
- Supplement
- S012
- Product code
- QSK
- Generic name
- Hybrid stent graft, thoracic aortic lesion treatment
- Decision date
- 2025-04-09
- Decision code
- OK30
- Date received
- 2025-03-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- changes to the bioburden and cleanroom monitoring processes and addition of a new manufacturing equipment for the Thoraflex Hybrid