Poly-Plating’s Nickel Plating Process Earns Accepted Status from FDA

Device Master Files (MAFS) available for those seeking a Premarket Application (PMA) or 510(k) approval for medical devices with the Food and Drug Administration.

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Poly-Plating Inc., a metal plating facility located in Chicopee, Massachusetts, has made its Device Master Files (MAFS) available for those seeking a Premarket Application (PMA) or 510(k) approval for medical devices with the Food and Drug Administration.

 

 

Poly-Plating’s submission for an MAF for its proprietary Poly-Ond process has been accepted by the FDA. MAFs are repositories of confidential information used in support of a PMA or 510(k) submission. To help preserve the trade secrets of the ancillary medical device industry and at the same time facilitate the sound scientific evaluation of medical devices, the FDA established the device master file system.

 

Those seeking FDA approval for a device that utilizes the Poly-Ondprocess may request authorization from Poly-Plating to allow information in the MAF to be submitted as part of the approval process.

 

Poly-Plating, Inc. is a cutting-edge, innovative nickel and metal plating company based in Chicopee, MA. The company excels in the plating of precision parts for an array of industries worldwide including military, mold-making, and medical applications. Along with the proprietary Poly-Ond®, company processes include Sulfamate and Electroless nickel plating.

 

For more information on Poly-Plating, Inc, call (413) 593-5477 or visit http://www.poly-ond.com