PMA P010038S010

Device
SECOND LOOK
Applicant
Icad, Inc.
PMA number
P010038
Supplement
S010
Product code
MYN
Decision date
2006-01-13
Classification
Analyzer, Medical Image
Generic name
Analyzer, medical image
Approval order statement
APPROVAL FOR A MANUFACTURING SITE LOCATED AT INFUMEDICS, INC., EAST WALPOLE, MASSACHUSETTS.

Current openFDA PMA Record#

Device
SECOND LOOK
Applicant
Icad, Inc.
PMA number
P010038
Supplement
S010
Product code
MYN
Generic name
Analyzer, medical image
Decision date
2006-01-13
Decision code
APPR
Date received
2005-10-18
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Express GMP Supplement
Approval order statement
APPROVAL FOR A MANUFACTURING SITE LOCATED AT INFUMEDICS, INC., EAST WALPOLE, MASSACHUSETTS.