MagtraceTM and Sentimag(R) Magnetic Locatization System

FDA Premarket Approval P160053 S005

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

• Device: MagtraceTM and Sentimag(R) Magnetic Locatization System
• Generic Name: Lymph Node Location System During Sentinel Biopsy Procedure
• Applicant: ENDOMAGNETICS LTD.330 Cambridge Science Park, Milton Roadcambridge CB4 0 PMA NumberP160053 Supplement NumberS005 Date Received03/24/2022 Decision Date09/13/2022 Product Code PUV Advisory Committee General & Plastic Surgery Supplement Typenormal 180 Day Track Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• Date Received: 2022-03-24
• Decision Date: 2022-09-13
• PMA: P160053
• Supplement: S005
• Product Code: PUV
• Advisory Committee: General & Plastic Surgery
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Change Design/components/specifications/material
• Expedited Review: No
• Combination Product: Yes
• Applicant Address: ENDOMAGNETICS LTD.; 330 Cambridge Science Park, Milton Road; cambridge CB4 0 PMA NumberP160053 Supplement NumberS005 Date Received03/24/2022 Decision Date09/13/2022 Product Code PUV Advisory Committee General & Plastic Surgery Supplement Typenormal 180 Day Track Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No Combination ProductYes Approval Order Statement ; Approved For Using New Gen 3 And Gen 3T Sentimag Detectors To Detect Magtrace, Addition Of CIDEX OPA As A High Level Disinfectant For Disinfecting Sentimag Gen 3 And Gen 3T Detectors, And Addition Of Certain Low Temperature Sterilization Systems For Certain Cycles For Sterilization Of Sentimag Gen 3 And Gen 3T Detectors.

Supplemental Filings

Supplement Number	Date	Supplement Type
P160053		Original Filing
S005	2022-03-24	Normal 180 Day Track
S004	2021-04-01	Normal 180 Day Track No User Fee
S003	2018-11-26	30-day Notice
S002
S001	2018-07-30	Real-time Process

NIH GUDID Devices

Device ID	PMA	Supp
15060391210244	P160053	000