PMA P110038S014
- Device
- RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM
- Applicant
- Bolton Medical, Inc.
- PMA number
- P110038
- Supplement
- S014
- Product code
- MIH
- Decision date
- 2016-10-13
- Classification
- System, Endovascular Graft, Aortic Aneurysm Treatment
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- Use of an automatic drilling machine in the manufacture of the rotator body component of the Relay Thoracic Stent-Graft Plus Delivery System.
Current openFDA PMA Record#
- Device
- RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM
- Applicant
- Bolton Medical, Inc.
- PMA number
- P110038
- Supplement
- S014
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2016-10-13
- Decision code
- OK30
- Date received
- 2016-09-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Use of an automatic drilling machine in the manufacture of the rotator body component of the Relay Thoracic Stent-Graft Plus Delivery System.