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# Prostatic Artery Embolization Device into Class 2
- URL: https://www.fdaweb.com/prostatic-artery-embolization-device-into-class-2/
- Published: 2017-11-14T12:00:00.000Z
- Updated: 2026-09-14T23:01:35.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5140129

*Federal Register* notice: FDA has classified the prostatic artery embolization device into Class 2 (special controls). The action was in response to a 2016 BioSphere Medical *de novo* classification request for the Embosphere Microspheres. The agency has codified the classification by adding 21 CFR 876.5550 and naming the generic type of device “prostatic artery embolization device.” It is identified as an intravascular implant intended to occlude the prostatic arteries to prevent blood flow to the targeted area of the prostate, resulting in a reduction of lower urinary tract symptoms related to benign prostatic hyperplasia. This does not include cyanoacrylates and other embolic agents which act by *in situ* polymerization or precipitation, or embolization devices used in neurovascular applications. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2017-11-14/pdf/2017-24586.pdfhttps:/www.gpo.gov/fdsys/pkg/FR-2017-11-14/pdf/2017-24586.pdf?ref=fdaweb.com).