PMA P110038S010
- Device
- RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM
- Applicant
- Bolton Medical, Inc.
- PMA number
- P110038
- Supplement
- S010
- Product code
- MIH
- Decision date
- 2015-11-18
- Classification
- System, Endovascular Graft, Aortic Aneurysm Treatment
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- APPROVAL FOR AN ADDITIONAL INSPECTION STEP OF THE RELEASE GRIP.
Current openFDA PMA Record#
- Device
- RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM
- Applicant
- Bolton Medical, Inc.
- PMA number
- P110038
- Supplement
- S010
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2015-11-18
- Decision code
- APPR
- Date received
- 2015-10-19
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR AN ADDITIONAL INSPECTION STEP OF THE RELEASE GRIP.