RelayPlus Thoracic Stent-Graft System
FDA premarket approval P110038/S027 · decided 2023-01-20
Approval details
- PMA number
- P110038
- Supplement
- S027
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- RelayPlus Thoracic Stent-Graft System
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Bolton Medical, Inc.
- Date received
- 2022-12-23
- Decision date
- 2023-01-20
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sunrise, FL
- Statement
- Approval for implementation of updates to the procedural guidance in the Instructions for Use (IFU) and MR compatibility information in the IFU and patient implant card.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| BOLTON PTA CATHETER (K021996) | Bolton Medical, Inc. | 2002-08-23 |