PMA P200045S001
- Device
- RelayPro Thoracic Stent-Graft System
- Applicant
- Bolton Medical, Inc.
- PMA number
- P200045
- Supplement
- S001
- Product code
- MIH
- Decision date
- 2021-11-16
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- Approval of the protocol for the RelayPro Post Approval Surveillance Study.
Current openFDA PMA Record#
- Device
- RelayPro Thoracic Stent-Graft System
- Applicant
- Bolton Medical, Inc.
- PMA number
- P200045
- Supplement
- S001
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2021-11-16
- Decision code
- APPR
- Date received
- 2021-09-03
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval of the protocol for the RelayPro Post Approval Surveillance Study.