PMA P110038S012
- Device
- RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM
- Applicant
- Bolton Medical, Inc.
- PMA number
- P110038
- Supplement
- S012
- Product code
- MIH
- Decision date
- 2016-09-19
- Classification
- System, Endovascular Graft, Aortic Aneurysm Treatment
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- Approval for an alternate material and joining method for the delivery system secondary sheath (also referred to as the constraining sleeve).
Current openFDA PMA Record#
- Device
- RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM
- Applicant
- Bolton Medical, Inc.
- PMA number
- P110038
- Supplement
- S012
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2016-09-19
- Decision code
- APPR
- Date received
- 2016-06-21
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for an alternate material and joining method for the delivery system secondary sheath (also referred to as the constraining sleeve).