PMA P110038S024
- Device
- Relay Thoracic Stent-Graft with Plus Delivery System
- Applicant
- Bolton Medical, Inc.
- PMA number
- P110038
- Supplement
- S024
- Product code
- MIH
- Decision date
- 2019-10-30
- Classification
- System, Endovascular Graft, Aortic Aneurysm Treatment
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- Change to the delivery system hydrophilic coating process and test specifications.
Current openFDA PMA Record#
- Device
- Relay Thoracic Stent-Graft with Plus Delivery System
- Applicant
- Bolton Medical, Inc.
- PMA number
- P110038
- Supplement
- S024
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2019-10-30
- Decision code
- OK30
- Date received
- 2019-09-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to the delivery system hydrophilic coating process and test specifications.