September 21, 2005 To: Food and Drug Administration Office of Management Programs Division of Freedom of Information (HFI-35) 5600 Fishers Lane Rockvxtle, MD 20857 fax: (301) 443-1726 From : Je.anne Sears, MS, RN Department of Health Services University of Washington Box 357660 Seattle, WA 98195 (425) 828-4241 NO a ca -,~ c7 jeatanes@u.washington-edu c>" w Re- FOIA Request We are requesting copies of ail scientific studies and research data, including references to other supporting data or literature, that was submitted in support of supplement S020 for PMA # P860004. This is for the Medtronic SynchroMed programmable pump, specifically the added indication for pain of non-malaignant origin approved in 1991 . We are willing to pay the fees specified for nonconuuercial use requestors. Thank you very much, Jeanne Sears 05-13211 RECEIVE= SEP 2 3 2005 DIVISION OF F01 FDA DF01(HFI35) ~V REQUESTER TYPE: REQUESTER CATEGORY.-~ id wds0 :e0 s0ez tz 'das imbezeszv : 'ON XHA N~~NSw'sa1eas auupar : woNA