MANTA Vascular Closure

FDA Premarket Approval P180025 S006

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

Individually package the 8f depth locator

DeviceMANTA Vascular Closure
Generic NameDevice, Hemostasis, Vascular
ApplicantEssential Medical, Inc.
Date Received2020-01-06
Decision Date2020-01-23
PMAP180025
SupplementS006
Product CodeMGB 
Advisory CommitteeCardiovascular
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
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
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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