Relay Thoracic Stent-Graft with Plus Delivery System
FDA premarket approval P110038/S025 · decided 2020-12-17
Approval details
- PMA number
- P110038
- Supplement
- S025
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Relay Thoracic Stent-Graft with Plus Delivery System
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Bolton Medical, Inc.
- Date received
- 2020-11-24
- Decision date
- 2020-12-17
- Days to decision
- 23 days
- Decision code
- OK30
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sunrise, FL
- Statement
- a change to the nylon sub-supplier, the anti-block additive used, and the extrusion process used in the manufacturing of the product pouches for the Treo Abdominal Stent-Graft System and the Relay Thoracic Stent-Graft with Plus Delivery System
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| BOLTON PTA CATHETER (K021996) | Bolton Medical, Inc. | 2002-08-23 |