RelayPlus
FDA premarket approval P110038/S034 · decided 2025-09-03
Approval details
- PMA number
- P110038
- Supplement
- S034
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- RelayPlus
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Bolton Medical, Inc.
- Date received
- 2025-08-04
- Decision date
- 2025-09-03
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sunrise, FL
- Statement
- a material change for delivery system tips for the RelayPro Thoracic Stent-Graft System, RelayPlus Thoracic Stent-Graft System, and TREO Abdominal Stent-Graft System
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| BOLTON PTA CATHETER (K021996) | Bolton Medical, Inc. | 2002-08-23 |