FDA-Device2022-05-04Class II
SpaceOAR System, UPN SO-1010, SO-2101, SO-3101, and SO-4101. Used to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer to reduce the radiation dose delivered to the anterior rectum.
Boston Scientific Corporation
Hazard
Users need to be aware that embolism is a possible adverse event associated with hydrogel misplacements. Updated IFU provides new procedural instructions, warnings and precautions that describe steps to verify correct placement of the hydrogel following implantation, as well as technique recommendations for the proper placement of SpaceOAR and SpaceOAR Vue.
Sold states
Worldwide - US Nationwide distribution.
Affected count
61,852 units
Manufactured in
100 Boston Scientific Way, Marlborough, MA, United States
Products
SpaceOAR System, UPN SO-1010, SO-2101, SO-3101, and SO-4101. Used to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer to reduce the radiation dose delivered to the anterior rectum.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1002-2022Don't want to check this manually?
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