MANTA Vascular Closure

FDA Premarket Approval P180025 S008

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

Implementation of keyence systems to aid the toggle tuck inspection, to automate the suture spooling inspection, and to automate the toggle angle inspection

DeviceMANTA Vascular Closure
Generic NameDevice, Hemostasis, Vascular
ApplicantEssential Medical, Inc.
Date Received2020-08-21
Decision Date2020-09-18
PMAP180025
SupplementS008
Product CodeMGB 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Essential Medical, Inc. 260 Sierra Drive suite 120 exton, PA 19341

Supplemental Filings

Supplement NumberDateSupplement Type
P180025Original Filing
S008 2020-08-21 30-day Notice
S007 2020-05-04 30-day Notice
S006 2020-01-06 Real-time Process
S005 2019-07-23 30-day Notice
S004
S003
S002 2019-04-18 30-day Notice
S001

NIH GUDID Devices

Device IDPMASupp
00856279007079 P180025 000
00856279007062 P180025 000

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