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/Complianceread more
Source: Mass Device - Category: Medical Equipment Authors: Source Type: news