PMA P110038S009
- Device
- RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM
- Applicant
- Bolton Medical, Inc.
- PMA number
- P110038
- Supplement
- S009
- Product code
- MIH
- Decision date
- 2015-03-06
- Classification
- System, Endovascular Graft, Aortic Aneurysm Treatment
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- APPROVAL TO INCREASE THE RATE OF ENROLLMENT TO A MORE ACCEPTABLE RATE IN THE POST-APPROVAL STUDY PROTOCOL.
Current openFDA PMA Record#
- Device
- RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM
- Applicant
- Bolton Medical, Inc.
- PMA number
- P110038
- Supplement
- S009
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2015-03-06
- Decision code
- APPR
- Date received
- 2015-01-06
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Approval order statement
- APPROVAL TO INCREASE THE RATE OF ENROLLMENT TO A MORE ACCEPTABLE RATE IN THE POST-APPROVAL STUDY PROTOCOL.