Croma-Pharma GmbH

Croma-Pharma GmbH specializes in high-risk medical devices, specifically the saypha® MagIQ™. This device falls under the category of transcatheter aortic valve replacements (TAVR), designed for patients with aortic stenosis who need minimally invasive valve replacement. The classification as a Class III device indicates it carries significant risk and requires rigorous regulatory oversight.

Croma-Pharma GmbH is based in the United States. Since its device, the saypha® MagIQ™, is classified as a Class III medical device, it must comply with the FDA’s Premarket Approval (PMA) pathway. This pathway is reserved for high-risk devices and ensures that the device’s safety and effectiveness have been thoroughly evaluated before market authorization.

The saypha® MagIQ™, manufactured by Croma-Pharma GmbH, is listed in the FDA’s regulatory database under the Premarket Approval (PMA) pathway. This listing reflects the device’s classification as a Class III product, which requires pre-market authorization due to its associated risks and intended use in critical procedures like TAVR.

The saypha® MagIQ™ is classified as a Class III device because it is intended for use in transcatheter aortic valve replacement (TAVR), a procedure that carries significant risks to patient safety. Class III classification under FDA regulations means the device must undergo a rigorous Premarket Approval (PMA) process. This pathway ensures that the device’s benefits outweigh its risks through comprehensive clinical data and safety evaluations before it can be authorized for market.