Canada licensed six pulsed field devices a median of 84 days after the FDA

Health Canada licensed Varipulse (licence 111495) on 11 July 2024, 118 days before the FDA approved the Varipulse platform. Affera's licence (115505) followed its FDA approval by 587 days. Across the six confirmed pairs, the median gap is 84 days after the FDA decision.

Agency record, Licence 111495: Health Canada licence record

20 to 27 September 2026

0FDA PMA decisions
0510(k) clearances
0Canadian EP licences first issued

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