FDA down-classifies Ergon Medical's Prolong PE device

The FDA down-classifies Ergon Medical's Prolong premature ejaculation treatment from Class III to Class II.

The FDA said it down-classified the Prolong device, a vibrator used to treat premature ejaculation, from Class III to Class II after a request from Ergon Medical Ltd., creator of the device.

Ergon Medical Ltd., Food & Drug Administration (FDA)

News Well, Regulatory/Compliance

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