VENTAK P

FDA Premarket Approval P890061 S024

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

To implement the global labeling system version 3. 0 at select locations

DeviceVENTAK P
Generic NameImplantable Cardioverter Defibrillator (non-crt)
ApplicantBOSTON SCIENTIFIC
Date Received2021-03-08
Decision Date2021-04-02
PMAP890061
SupplementS024
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 0000-00-00
S021 0000-00-00
S020 0000-00-00
S019 0000-00-00
S018 0000-00-00
S017 0000-00-00
S016
S015
S014
S013 0000-00-00
S012 0000-00-00
S011 0000-00-00
S010 0000-00-00
S009 0000-00-00
S008 0000-00-00
S007
S006 0000-00-00
S005 0000-00-00
S004
S003 0000-00-00
S002 0000-00-00
S001 0000-00-00

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.