PMA P880006S033

Device
V.1 2a Programmer Software
Applicant
St. Jude Medical, Inc.
PMA number
P880006
Supplement
S033
Decision date
2000-09-07

Current openFDA PMA Record

Device
V.1 2A PROGRAMMER SOFTWARE
Applicant
St. Jude Medical, Inc.
PMA number
P880006
Supplement
S033
Product code
KRG
Generic name
Programmer, pacemaker
Decision date
2000-09-07
Decision code
APPR
Date received
2000-08-11
Supplement type
Normal 180 Day Track
Supplement reason
Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
APPROVAL FOR THE ALTERNATE MANUFACTURING FACILITY AT INNOMEDICA, INC., MINNEAPOLIS, MN AND THE ALTERNATE STERILIZATION FACILITY AT STERIS ISOMEDIX, MINNEAPOLIS, MN.

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