RelayPro Thoracic Stent-Graft System
FDA premarket approval P200045/S012 · decided 2024-07-18
Approval details
- PMA number
- P200045
- Supplement
- S012
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- RelayPro Thoracic Stent-Graft System
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Bolton Medical, Inc.
- Date received
- 2024-06-21
- Decision date
- 2024-07-18
- Days to decision
- 27 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sunrise, FL
- Statement
- Approval for Instructions for Use (IFU) updates for the TREO Abdominal Stent-Graft System and the RelayPro Thoracic 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 |