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