TREO® Abdominal Stent-Graft System
FDA premarket approval P190015/S016 · decided 2024-05-22
Approval details
- PMA number
- P190015
- Supplement
- S016
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- TREO® Abdominal Stent-Graft System
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Bolton Medical, Inc.
- Date received
- 2024-03-18
- Decision date
- 2024-05-22
- Days to decision
- 65 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sunrise, FL
- Statement
- approval for a manufacturing site Terumo Aortic Glasgow located at Newmains Ave, Inchinnan, Glasgow PA4 9RR, United Kingdom for manufacture of the Delivery System subassembly, loading of the Stent-Graft subassembly onto the Delivery System, and non-sterile packaging of the loaded Delivery System subassemblies of the Bifurcate and Cuff components of the TREO® Abdominal Stent-Graft System
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| BOLTON PTA CATHETER (K021996) | Bolton Medical, Inc. | 2002-08-23 |