FDA-Device2022-12-14Class II
Propel Mini Mometasone Furoate Sinus Implant, with Straight Delivery System, REF 60044
Intersect ENT, Inc.
Hazard
Sinus Implant product label displays incorrect product information including: "Straight Delivery System", with incorrect reference number and UDI-DI.
Sold states
US Nationwide distribution including in the states of NC, IL, KS, OR, WI, TX, FL, MN, WY, UT, NY, CA, NJ, OK, MD, HI, MT, TN, MO, IA, MA, AZ, GA, LA, ID, SC, WA, SD, ND, CO, NV.
Affected count
611 units
Manufactured in
1555 Adams Dr, N/A, Menlo Park, CA, United States
Products
Propel Mini Mometasone Furoate Sinus Implant, with Straight Delivery System, REF 60044
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0458-2023Don't want to check this manually?
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