PMA P160053S003

Device
MagtraceTM and Sentimag(R) Magnetic Locatization System
Applicant
Endomagnetics Ltd.,
PMA number
P160053
Supplement
S003
Product code
PUV
Decision date
2018-12-28
Classification
Lymph Node Location System During Sentinel Biopsy Procedure
Generic name
Lymph node location system during sentinel biopsy procedure
Approval order statement
Storing the subject product at a new storage site in Endomagnetics Ltd. in Cambridge, United Kingdom.
Summary
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Current openFDA PMA Record#

Device
MagtraceTM and Sentimag(R) Magnetic Locatization System
Applicant
Endomagnetics Ltd.,
PMA number
P160053
Supplement
S003
Product code
PUV
Generic name
Lymph node location system during sentinel biopsy procedure
Decision date
2018-12-28
Decision code
OK30
Date received
2018-11-26
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Storing the subject product at a new storage site in Endomagnetics Ltd. in Cambridge, United Kingdom.