PMA P110038S020
- Device
- Relay Thoracic Stent-Graft with Plus Delivery System
- Applicant
- Bolton Medical, Inc.
- PMA number
- P110038
- Supplement
- S020
- Product code
- MIH
- Decision date
- 2018-11-08
- Classification
- System, Endovascular Graft, Aortic Aneurysm Treatment
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- Changes to the manual sewing process for the delivery system inner sheath.
Current openFDA PMA Record#
- Device
- Relay Thoracic Stent-Graft with Plus Delivery System
- Applicant
- Bolton Medical, Inc.
- PMA number
- P110038
- Supplement
- S020
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2018-11-08
- Decision code
- OK30
- Date received
- 2018-10-05
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Changes to the manual sewing process for the delivery system inner sheath.