Document oe4k6LmJkqygyJ6xLJpk9No47

BFGoodrich The BFGoodrich Company Geon Vinyl Division 6100 Oak Tree Boulevard Cleveland, Ohio 44131 216-447-6000 February 12, 1992 Ati-Sle&C, n,' , qJj { Nicholas A. Marra Arzco Medical Systems, Inc. New Product Development Group 1029 Butterfield Rd. Vernon Hills, IN 60061 Re: Geon 86312 Trans 002 Dear Mr. Marra: Recent correspondence to Wallace C. Bachtel, who is deceased, has been directed to my attention. The technical data sheet on Geon 86312 Trans 002 is no longer valid. There has been a change in the formulation due to a pigment ingredient which FDA has removed from their clearance list. tqs.Consequently, the compound does not meet the current FDA requirements under 21CFR. 300, 177.1210, and does not have GRAS (Generally Recognized As Safe) or Prior Sanctioned status. Geon 86312 Trans has been replaced with Geon 86412 which has FDA acceptance, but has not been tested to meet USP requirements. If I can be of further assistance, give me a call on 216/447-7831. Sincerely, THE BFGOODRICH COMPANY QtlLfiv ________ Connie N. Dillon Regulatory and Data System Specialist (216) 447-7831 CN/rm ARZCO BFG14762