PMA P110038S015
- Device
- Relay Thoracic Stent-Graft with Plus Delivery System
- Applicant
- Bolton Medical, Inc.
- PMA number
- P110038
- Supplement
- S015
- Product code
- MIH
- Decision date
- 2017-05-01
- Classification
- System, Endovascular Graft, Aortic Aneurysm Treatment
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- Change in frequency of the sterilization dose audit.
Current openFDA PMA Record#
- Device
- Relay Thoracic Stent-Graft with Plus Delivery System
- Applicant
- Bolton Medical, Inc.
- PMA number
- P110038
- Supplement
- S015
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2017-05-01
- Decision code
- OK30
- Date received
- 2017-04-07
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change in frequency of the sterilization dose audit.