Data / Medical devices / United States / Bolton Medical, Inc.
Bolton Medical, Inc.: FDA-registered device maker in Sunrise, FL, United States, 3 PMA approvals
Bolton Medical, Inc. is registered with the FDA (registration 2247858) in Sunrise, FL, United States. It lists 1 device type. The FDA files 3 PMA approvals under its listings, the newest dated August 5, 2021. 4 recall events name it as the recalling firm (1 Class I). Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2247858
- FEI number
- 1000135961
- Address
- 799 International Pkwy, Sunrise, FL, United States, 33325
- Owner or operator
- BOLTON MEDICAL, INC. (9007572)
- Roles
- Manufacturer, Manufacturer for export
- First device listed
- November 21, 2007
- Registered through
- 2026
- Brand names listed
- Relay NBS Plus Stent -Graft System, Relay Plus Thoracic Stent-Graft System, Relay Thoracic Stent-Graft with Plus Delivery System, Relay Thoracic Stent-Graft with Transport Delivery System, RelayPro Thoracic Stent Graft System, RelayPro Thoracic Stent-Graft System, TREO AUI Stent-Graft System, TREO Abdominal Stent-Graft System and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Endovascular Graft, Aortic Aneurysm Treatment | MIH | 3 | Manufacturer, Manufacturer for export | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| August 5, 2021 | P200045 | RelayPro Thoracic Stent-Graft System | MIH | 20 | June 18, 2026 | accessdata.fda.gov |
| May 4, 2020 | P190015 | TREO® Abdominal Stent-Graft System | MIH | 27 | June 18, 2026 | accessdata.fda.gov |
| September 21, 2012 | P110038 | RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM | MIH | 30 | October 10, 2025 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| April 22, 2026 | 98729 | Class I | Ongoing | RelayPro Thoracic Stent-Graft System (various sizes) Reference numbers: 28-N4-32-104-32U 28-N4-32-164-28U 28-N4-32-164-32U 28-N4-32-209-28U 28-N4-32-209-32U 28-N4-32-259-32U 28-N4-34-109-34U 28-N4-34-154-30U 28-N4-34-154 | Labeling update concerning proximal clasp disconnection from the outer control tube which may prevent stent graft from being released from the delivery system. | accessdata.fda.gov |
| February 22, 2024 | 93873 | Class II | Completed | RELAY PRO Thoracic Stent-Graft System, containing one endovascular stent-graft system, IFU, and patient tracking card, sterile: (a) Part number 28-M4-34-100-34U; (b) Part number 28-M4-30-095-30U; (c) Part number 28-M4-46 | The stent-graft inside the delivery system was the incorrect size. | accessdata.fda.gov |
| May 3, 2023 | 92252 | Class II | Ongoing | The TREO ABDOMINAL STENT-GRAFT SYSTEM (TREO) consists of four types of implants, specifically a Main Bifurcated Stent-Graft, a Leg Extension Stent-Graft, a Proximal Cuff Stent-Graft and a Straight Iliac Extension Stent-G | Potential for the incorrect size stent-graft than the printed carton label. | accessdata.fda.gov |
| December 20, 2022 | 91292 | Class II | Ongoing | RELAY PRO, THORACIC STENT-GRAFT SYSTEM, REF 28-M4-XX-XXX-XXX | The product may be shorter than packaging indicates | accessdata.fda.gov |
Compare with other makers
Updated June 18, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.