CELT ACD VASCULAR CLOSURE DEVICE

Device, Hemostasis, Vascular

FDA Premarket Approval P150006 S001

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

Approval for the addition of a 7f size celt acd vascular closure device and minor manufacturing and design changes to the 5f, 6f, and 7f celt acd vascular closure devices.

DeviceCELT ACD VASCULAR CLOSURE DEVICE
Classification NameDevice, Hemostasis, Vascular
Generic NameDevice, Hemostasis, Vascular
ApplicantVASORUM LTD
Date Received2016-10-17
Decision Date2017-06-27
PMAP150006
SupplementS001
Product CodeMGB
Advisory CommitteeCardiovascular
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address VASORUM LTD 2012 Orchard Ave citywest Business Campus dublin 24

Supplemental Filings

Supplement NumberDateSupplement Type
P150006Original Filing
S004 2019-08-13 30-day Notice
S003
S002
S001 2016-10-17 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
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
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