FDA-Device2020-10-07Class II
Pacific Xtreme (PTCA Balloon Dilation Catheter)
ev3 Inc.
Hazard
Labeling discrepancy for the Rated Burst Pressure (RBP) value.
Sold states
Domestic Distribution: AL, AR, AZ, CA, CO, DC, DE, FL, GA, IA, IL,IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OR, PA, RI, SC, SD, TN, TX,VA, WA, WI and WV. International Distribution: Canada and Puerto Rico.
Affected count
4286 devices
Manufactured in
4600 Nathan Ln N, N/A, Plymouth, MN, United States
Products
Pacific Xtreme (PTCA Balloon Dilation Catheter)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3055-2020Don't want to check this manually?
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