RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM
FDA premarket approval P110038/S033 · decided 2025-10-10
Approval details
- PMA number
- P110038
- Supplement
- S033
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Bolton Medical, Inc.
- Date received
- 2025-04-10
- Decision date
- 2025-10-10
- Days to decision
- 183 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sunrise, FL
- Statement
- approval for labeling updates to include the final study results of the Relay Thoracic Stent-Graft with Plus Delivery System Pivotal, Continued Access, and Post Approval Studies
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| BOLTON PTA CATHETER (K021996) | Bolton Medical, Inc. | 2002-08-23 |