PMA P110038S023
- Device
- Relay Thoracic Stent-Graft with Plus Delivery System
- Applicant
- Bolton Medical, Inc.
- PMA number
- P110038
- Supplement
- S023
- Product code
- MIH
- Decision date
- 2019-04-19
- Classification
- System, Endovascular Graft, Aortic Aneurysm Treatment
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- Specification change for the amount of adhesive allowed on the Delivery Tube.
Current openFDA PMA Record#
- Device
- Relay Thoracic Stent-Graft with Plus Delivery System
- Applicant
- Bolton Medical, Inc.
- PMA number
- P110038
- Supplement
- S023
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2019-04-19
- Decision code
- OK30
- Date received
- 2019-03-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Specification change for the amount of adhesive allowed on the Delivery Tube.