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# nteger Holdings PMA Approved for RadialSeal
- URL: https://www.fdaweb.com/nteger-holdings-pma-approved-for-radialseal/
- Published: 2018-07-31T12:00:00.000Z
- Updated: 2026-09-15T00:22:51.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5142012

FDA has approved an Integer Holdings PMA for its radial access introducer RadialSeal. The device was designed using the company’s guidewires and hemostatic introducers. The company says it has optimal treatment flexibility provided by a thin walled sheath design that minimizes outer diameter while maximizing inner diameter, and ease of sheath insertion through smooth transitions and hydrophilic coats. It is intended for use in interventional cardiology and peripheral vascular procedures.