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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceRELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM
Generic NameSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
ApplicantBOLTON MEDICAL, INC.
799 INTERNATIONAL PARKWAY
SUNRISE, FL 33325
PMA NumberP110038
Date Received11/04/2011
Decision Date09/21/2012
Product Code MIH 
Docket Number 12M-1012
Notice Date 10/02/2012
Advisory Committee Cardiovascular
Clinical TrialsNCT00435942
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM. THIS DEVICE IS INDICATED FOR THE ENDOVASCULAR REPAIR OF FUSIFORM ANEURYSMS AND SACCULAR ANEURYSMS/ PENETRATING ATHEROSCLEROTIC ULCERS IN THE DESCENDING THORACIC AORTA IN PATIENTS HAVING APPROPRIATE ANATOMY, INCLUDING: 1) ILIAC OR FEMORAL ACCESS VESSEL MORPHOLOGY THAT IS COMPATIBLE WITH VASCULAR ACCESS TECHNIQUES, DEVICES AND/OR ACCESSORIES; 2) NON-ANEURYSMAL AORTIC NECK DIAMETER IN THE RANGE OF 19 - 42 MM; AND 3) NON-ANEURYSMAL PROXIMAL AORTIC NECK LENGTHS BETWEEN 15 AND 25 NUN AND DISTAL AORTIC NECK LENGTHS BETWEEN 25 AND 30 MM DEPENDING ON THE DIAMETER STENT-GRAFT REQUIRED.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S002 S004 S005 S006 S008 S009 S010 S011 S012 S013 
S014 S015 S016 S017 S018 S020 S021 S022 S023 S024 S025 S026 
S027 S029 S030 S031 
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