TRUFILL n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System

Tissue Adhesive For Use In Embolization Of Brain Arteriovenous Malformations

FDA Premarket Approval P990040 S029

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

A change to the bha concentration specified for n-bca during manufacture, prior to the dry heat sterilization process.

DeviceTRUFILL n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System
Classification NameTissue Adhesive For Use In Embolization Of Brain Arteriovenous Malformations
Generic NameTissue Adhesive For Use In Embolization Of Brain Arteriovenous Malformations
ApplicantCODMAN & SHURTLEFF, INC.
Date Received2019-02-19
Decision Date2019-09-18
PMAP990040
SupplementS029
Product CodeKGG
Advisory CommitteeNeurology
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address CODMAN & SHURTLEFF, INC. 325 Paramount Drive raynham, MA 02767-0350

Supplemental Filings

Supplement NumberDateSupplement Type
P990040Original Filing
S029 2019-02-19 Normal 180 Day Track
S028 2018-11-15 30-day Notice
S027 2018-11-02 Normal 180 Day Track No User Fee
S026 2018-05-29 30-day Notice
S025 2017-06-08 30-day Notice
S024 2017-01-31 Normal 180 Day Track
S023 2016-11-14 30-day Notice
S022 2016-04-18 Normal 180 Day Track
S021 2015-08-28 30-day Notice
S020 2015-02-18 Real-time Process
S019 2014-09-17 Real-time Process
S018
S017 2013-09-16 135 Review Track For 30-day Notice
S016 2010-11-24 30-day Notice
S015 2010-11-08 Real-time Process
S014 2010-10-12 30-day Notice
S013 2010-08-18 135 Review Track For 30-day Notice
S012 2010-07-28 Real-time Process
S011 2010-05-10 30-day Notice
S010 2009-11-13 30-day Notice
S009 2009-08-31 Normal 180 Day Track No User Fee
S008 2009-03-13 30-day Notice
S007 2008-12-19 30-day Notice
S006 2007-11-01 30-day Notice
S005 2007-07-20 135 Review Track For 30-day Notice
S004 2006-04-28 Special (immediate Track)
S003 2006-02-09 30-day Notice
S002 2006-02-09 30-day Notice
S001 2001-03-01 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
10886704029151 P990040 001
10886704029144 P990040 001
10886704085324 P990040 031
10886704085317 P990040 031

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