WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Exit Postmarket & security

THE TAPE

Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets

The Tracker / June 2026 / P250021

PMA approved

saypha® ChiQ

Croma-Pharma GmbH · Jun 12, 2026 · P250021

FDA approved the saypha® ChiQ from Croma-Pharma GmbH on Jun 12, 2026 under P250021, an original premarket approval. The device falls under product code LMH, Implant, Dermal, For Aesthetic Use as a Class 3 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Jun 26, 2025. The decision came 351 days later.

This is the only decision on file for Croma-Pharma GmbH in the last 12 months of the tracker.

Questions & Answers

What did FDA approve under P250021?

P250021 is the FDA PMA for saypha® ChiQ, submitted by Croma-Pharma GmbH. FDA's decision date was Jun 12, 2026, under product code LMH (Implant, Dermal, For Aesthetic Use).

Who makes the saypha® ChiQ?

Croma-Pharma GmbH, based in Leobendorf, is the applicant of record for P250021.

How long did the P250021 review take?

FDA received the submission on Jun 26, 2025 and issued its decision on Jun 12, 2026, 351 days later.

← All decisions in June 2026