MANTA Vascular Closure

Device, Hemostasis, Vascular

FDA Premarket Approval P180025 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

To reduce the number of in-process inspections for pouch seal strength testing

• Device: MANTA Vascular Closure
• Classification Name: Device, Hemostasis, Vascular
• Generic Name: Device, Hemostasis, Vascular
• Applicant: Essential Medical, Inc.
• Date Received: 2019-07-23
• Decision Date: 2019-08-06
• PMA: P180025
• Supplement: S005
• Product Code: MGB
• Advisory Committee: Cardiovascular
• Supplement Type: 30-day Notice
• Supplement Reason: Process Change - Manufacturer/sterilizer/packager/supplier
• Expedited Review: No
• Combination Product: No
• Applicant Address: Essential Medical, Inc. 260 Sierra Drive suite 120 exton, PA 19341

Supplemental Filings

Supplement Number	Date	Supplement Type
P180025		Original Filing
S009	2021-02-10	Normal 180 Day Track
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 ID	PMA	Supp
00856279007079	P180025	000
00856279007062	P180025	000
20841156109957	P180025	000
20841156109933	P180025	000
20841156109926	P180025	000
20841156109902	P180025	000