PMA P160053S004

Device
Magtrace/and Sentimag Magnetic Localization System
Applicant
Endomagnetics Ltd.,
PMA number
P160053
Supplement
S004
Product code
PUV
Decision date
2021-09-20
Generic name
Lymph node location system during sentinel biopsy procedure
Approval order statement
Approval for site located at 305 Ashcake Road, Suite L, Ashland, Virginia 23005 USA

Current openFDA PMA Record#

Device
Magtrace/and Sentimag Magnetic Localization System
Applicant
Endomagnetics Ltd.,
PMA number
P160053
Supplement
S004
Product code
PUV
Generic name
Lymph node location system during sentinel biopsy procedure
Decision date
2021-09-20
Decision code
APPR
Date received
2021-04-01
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Approval for site located at 305 Ashcake Road, Suite L, Ashland, Virginia 23005 USA