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Device | RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM |
Generic Name | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT |
Applicant | BOLTON MEDICAL, INC. 799 INTERNATIONAL PARKWAY SUNRISE, FL 33325 |
PMA Number | P110038 |
Date Received | 11/04/2011 |
Decision Date | 09/21/2012 |
Product Code |
MIH |
Docket Number | 12M-1012 |
Notice Date | 10/02/2012 |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT00435942
|
Expedited Review Granted? | No |
Combination Product | No |
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 Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
|
Post-Approval Study | Show 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 S032 |