PMA P010038S014

Device
SECONDLOOK
Applicant
Icad, Inc.
PMA number
P010038
Supplement
S014
Product code
MYN
Decision date
2007-07-27
Classification
Analyzer, Medical Image
Generic name
Analyzer, medical image
Approval order statement
APPROVAL FOR A MANUFACTURING SITE LOCATED AT PROVEN PROCESS MEDICAL DEVICES, MANSFIELD, MASSACHUSETTS.

Current openFDA PMA Record#

Device
SECONDLOOK
Applicant
Icad, Inc.
PMA number
P010038
Supplement
S014
Product code
MYN
Generic name
Analyzer, medical image
Decision date
2007-07-27
Decision code
APPR
Date received
2007-04-02
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
APPROVAL FOR A MANUFACTURING SITE LOCATED AT PROVEN PROCESS MEDICAL DEVICES, MANSFIELD, MASSACHUSETTS.