TREO Abdominal Stent-Graft System
FDA premarket approval P190015/S007 · decided 2020-12-16
Approval details
- PMA number
- P190015
- Supplement
- S007
- 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
- 2020-11-23
- Decision date
- 2020-12-16
- Days to decision
- 23 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sunrise, FL
- Statement
- Approval for a manufacturing site located at Terumo Vietnam Co., Ltd (Lot 44A-B-C, Quang Minh Industrial Zone, Me Linh District, Hanoi City, Vietnam) for kitting and sewing processes of TREO Abdominal Stent Graft.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| BOLTON PTA CATHETER (K021996) | Bolton Medical, Inc. | 2002-08-23 |