FDA.reportPublic FDA data

PMA P190015S007

Device
TREO Abdominal Stent-Graft System
Applicant
Bolton Medical, Inc.
PMA number
P190015
Supplement
S007
Product code
MIH
Decision date
2020-12-16
Generic name
SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Approval order statement
Approval for a manufacturing site located at Terumo Vietnam Co., Ltd (Lot 44A-B-C, Quang Minh Industrial Zone, Me Linh District, Hanoi City, Vietnam) for kitting and sewing processes of TREO Abdominal Stent Graft.

Current openFDA PMA Record#

Device
TREO Abdominal Stent-Graft System
Applicant
Bolton Medical, Inc.
PMA number
P190015
Supplement
S007
Product code
MIH
Generic name
SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Decision date
2020-12-16
Decision code
APPR
Date received
2020-11-23
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Approval for a manufacturing site located at Terumo Vietnam Co., Ltd (Lot 44A-B-C, Quang Minh Industrial Zone, Me Linh District, Hanoi City, Vietnam) for kitting and sewing processes of TREO Abdominal Stent Graft.