CELT ACD Vascular Closure

Device, Hemostasis, Vascular

FDA Premarket Approval P150006 S004

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

An expanded e-beam sterilization dose range

• Device: CELT ACD Vascular Closure
• Classification Name: Device, Hemostasis, Vascular
• Generic Name: Device, Hemostasis, Vascular
• Applicant: VASORUM LTD
• Date Received: 2019-08-13
• Decision Date: 2019-08-26
• PMA: P150006
• Supplement: S004
• 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: VASORUM LTD 2012 Orchard Ave citywest Business Campus dublin 24

Supplemental Filings

Supplement Number	Date	Supplement Type
P150006		Original Filing
S004	2019-08-13	30-day Notice
S003
S002
S001	2016-10-17	Normal 180 Day Track

NIH GUDID Devices

Device ID	PMA	Supp
05391530280150	P150006	001
05391530280129	P150006	001
05391530280099	P150006	001
05391530280068	P150006	001
05391530280037	P150006	001
05391530280006	P150006	001
05391530280679	P150006	001
05391530280655	P150006	001
05391530280624	P150006	001