VENTAK P AICD SYSTEMS

FDA Premarket Approval P890061 S023

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

Use of new traceability/tracking software in the incoming receiving inspection area.

DeviceVENTAK P AICD SYSTEMS
Generic NameImplantable Cardioverter Defibrillator (non-crt)
ApplicantBOSTON SCIENTIFIC
Date Received2013-08-29
Decision Date2013-09-25
PMAP890061
SupplementS023
Product CodeLWS 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address BOSTON SCIENTIFIC 4100 Hamline Avenue North st. Paul, MN 55112

Supplemental Filings

Supplement NumberDateSupplement Type
P890061Original Filing
S024 2021-03-08 30-day Notice
S023 2013-08-29 30-day Notice
S022 2012-11-08 30-day Notice
S021 2012-10-10 30-day Notice
S020 2012-03-26 30-day Notice
S019 2011-04-01 30-day Notice
S018 2009-12-18 30-day Notice
S017 2009-12-16 30-day Notice
S016 2004-12-03 30-day Notice
S015 2004-10-21 30-day Notice
S014 2004-04-14 30-day Notice
S013 2000-08-21 Normal 180 Day Track
S012 1996-10-16 Normal 180 Day Track
S011 1995-06-26 Normal 180 Day Track
S010 1995-04-06 Normal 180 Day Track
S009 1994-12-14 Normal 180 Day Track
S008 1993-10-19 Normal 180 Day Track
S007
S006 1993-04-15 Normal 180 Day Track
S005 1992-08-26 Normal 180 Day Track
S004
S003 1992-04-29 Normal 180 Day Track
S002 1991-07-05 Normal 180 Day Track
S001 1991-05-07 Normal 180 Day Track

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.