TREO® Abdominal Stent-Graft System
FDA premarket approval P190015/S004 · decided 2020-12-03
Approval details
- PMA number
- P190015
- Supplement
- S004
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- TREO® Abdominal Stent-Graft System
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Bolton Medical, Inc.
- Date received
- 2020-09-04
- Decision date
- 2020-12-03
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sunrise, FL
- Statement
- Approval for an increase in the labeled shelf life for the bifurcate and cuff devices in the TREO Abdominal Stent-Graft System (TREO) product family from 2 years to 3 years.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| BOLTON PTA CATHETER (K021996) | Bolton Medical, Inc. | 2002-08-23 |