PMA P210006S015
- Device
- Thoraflex Hybrid
- Applicant
- Vascutek, Ltd.
- PMA number
- P210006
- Supplement
- S015
- Product code
- QSK
- Decision date
- 2025-10-29
- Classification
- Cardiovascular
- Generic name
- Hybrid stent graft, thoracic aortic lesion treatment
- Approval order statement
- removal of select incoming inspection steps and select incoming goods bioburden monitoring procedures for the Thoraflex Hybrid device
Current openFDA PMA Record
- Device
- Thoraflex Hybrid
- Applicant
- Vascutek, Ltd.
- PMA number
- P210006
- Supplement
- S015
- Product code
- QSK
- Generic name
- Hybrid stent graft, thoracic aortic lesion treatment
- Decision date
- 2025-10-29
- Decision code
- OK30
- Date received
- 2025-09-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- removal of select incoming inspection steps and select incoming goods bioburden monitoring procedures for the Thoraflex Hybrid device