Data / Medical devices / United States / Intersect Ent
Intersect Ent: FDA-registered device maker in Menlo Park, CA, United States, 1 PMA approval
Intersect Ent is registered with the FDA (registration 3008301917) in Menlo Park, CA, United States. It lists 1 device type. The FDA files 1 PMA approval under its listings, the newest dated August 11, 2011. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008301917
- Address
- 1555 Adams Dr, Menlo Park, CA, United States, 94025
- Owner or operator
- Medtronic, Inc. (2112641)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- November 10, 2022
- Registered through
- 2026
- Brand names listed
- Propel Contour Sinus Implant, Propel Mini Sinus Implant, Propel Mini Sinus Implant with Straight Deliver System (SDS), Propel Sinus Implant
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Drug-Eluting Sinus Stent | OWO | 3 | Complaint file establishment, Manufacturer | 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 11, 2011 | P100044 | PROPEL | OWO | 59 | September 23, 2026 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| October 21, 2022 | 91063 | Class II | Ongoing | Propel Mini Mometasone Furoate Sinus Implant, with Straight Delivery System, REF 60044 | Sinus Implant product label displays incorrect product information including: "Straight Delivery System", with incorrect reference number and UDI-DI. | accessdata.fda.gov |
Updated September 23, 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.