TREO Abdominal Stent-Graft System
FDA premarket approval P190015/S013 · decided 2023-12-13
Approval details
- PMA number
- P190015
- Supplement
- S013
- Supplement type
- 30-Day Notice
- Supplement reason
- Process 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
- 2023-11-17
- Decision date
- 2023-12-13
- Days to decision
- 26 days
- Decision code
- OK30
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sunrise, FL
- Statement
- modifications to the inspection plan for TREO stent-grafts that are manufactured at Terumo Vietnam Corporation (TVC)
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| BOLTON PTA CATHETER (K021996) | Bolton Medical, Inc. | 2002-08-23 |