RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM
FDA premarket approval P110038 · decided 2012-09-21
Approval details
- PMA number
- P110038
- Trade name
- RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Bolton Medical, Inc.
- Date received
- 2011-11-04
- Decision date
- 2012-09-21
- Days to decision
- 322 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sunrise, FL
- 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-ANEURYSM
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| BOLTON PTA CATHETER (K021996) | Bolton Medical, Inc. | 2002-08-23 |