INFUSION SYSTEMS, LL C
May 9, 200 8

Fooi and Drug Administration
Offic 9 of Management Program s
Divi; ion of Freedom of Information (HFI-35)
5601 , Fishers Lan e
Roc ville, MD 2085 7
FAA (309) 443-1726
Req i est for Information from CDRH:

FDA D ~OI (HF .3 ;

lnfu ; ion Systems, LLC requests a copy of the Summary of Safety and Effectiveness for the
follo ving products:
Codman 3000 Infusion Pump - P890055
Infusaid Infusion Pump - P800036
. Medtronic Synchromed Pump - P86000 4

No 'SEs were posted on the PMA data base for these devices. ISLLC would appreciat e
rece ving these documents via e-mail, If possible, Kindly send them to the attention of Peter Lord:
PLord (cDa d vancedbionics . co m

Sine mely yours,

/

Gen a Resch, MT (ASCP) RAC
Con ultant, Regulatory Affairs
lnfuc ion Systems, LL C
Tele 661-993-8080
e-m i il: gerdar@aemf.org

12744 San =ernando Road Bldg 3, Sylmar, CA 91342, Telephone (818) 833-5400, Fax (818) 367-9438