In my opinion, Implantica published a very significant FDA update regarding RefluxStop.
The company announced that it has submitted its “final response” to the FDA in the PMA process, including:
- the final additional tests
- responses to FDA questions
- processing of all 3 PMA modules
- and the successful completion of 6 pre-approval inspections (manufacturing, quality system, and BIMO)
Particularly positive:
- additional tests requested by the FDA have been completed
- no indications of new major research requirements
- inspections were passed without significant remarks
- the company’s tone is very confident.
Typically, at this stage, a decision can come within weeks or a few months, but FDA processes can always drag on. If approval is granted without major restrictions, this could be a truly massive turning point for Implantica in the US market.