Relay Thoracic Stent-Graft with Plus Delivery System
FDA premarket approval P110038/S021 · decided 2020-02-13
Approval details
- PMA number
- P110038
- Supplement
- S021
- Supplement type
- 135 Review Track For 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
- 2018-11-05
- Decision date
- 2020-02-13
- Days to decision
- 465 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sunrise, FL
- Statement
- Approval for added inspections and manufacturing process clarifications for the delivery system tip sub-assembly.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| BOLTON PTA CATHETER (K021996) | Bolton Medical, Inc. | 2002-08-23 |