The following Master Files {MAF} are now on file with the FDA. 

 

FDA MAF #	HYDROMER COATING FORMULA #
MAF-1391	2234-179
MAF-1394	3-TS-12
MAF-1395	2-TS-96
MAF-1408	2204-58
MAF-1417	2018-20M
MAF-1419	SM-1099
MAF-1487	2264-206 Non-leaching, Anti-Microbial Coating
MAF-1502	2276-169
MAF-1540	5-TS-83 Lubricious & Thrombo-Resistant
MAF-1541	2-TS-15 Primer

 

Customers can now request us to authorize reference to the MAFs in support of regulatory submissions.