VENTAK(R) P2 SYSTEM

FDA Premarket Approval P930035 S032

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

Add a new pallet sterilization chamber at the arden hills facility to increase sterilization capacity.

DeviceVENTAK(R) P2 SYSTEM
Generic NameImplantable Cardioverter Defibrillator (non-crt)
ApplicantBOSTON SCIENTIFIC
Date Received2021-04-30
Decision Date2021-05-10
PMAP930035
SupplementS032
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
P930035Original Filing
S032 2021-04-30 30-day Notice
S031 2021-03-08 30-day Notice
S030 2019-03-13 30-day Notice
S029 2018-03-26 30-day Notice
S028 2016-05-27 30-day Notice
S027 2014-06-30 30-day Notice
S026 2014-04-22 30-day Notice
S025 2013-08-29 30-day Notice
S024 2012-11-08 30-day Notice
S023 2012-10-10 30-day Notice
S022 2012-07-26 Real-time Process
S021 2012-03-26 30-day Notice
S020 2011-04-01 30-day Notice
S019 2009-12-18 30-day Notice
S018 2009-12-16 30-day Notice
S017
S016 2006-04-13 30-day Notice
S015 2006-04-13 30-day Notice
S014 2004-12-03 30-day Notice
S013 2004-10-21 30-day Notice
S012 2004-04-14 30-day Notice
S011 2003-10-30 Special (immediate Track)
S010 2002-11-13 30-day Notice
S009 2000-12-01 Real-time Process
S008 1997-09-30 Normal 180 Day Track
S007 1996-10-16 Normal 180 Day Track
S006 1996-09-05 Normal 180 Day Track
S005 1996-05-10 Normal 180 Day Track
S004 1995-06-26 Normal 180 Day Track
S003 1995-04-06 Normal 180 Day Track
S002 1995-03-30 Normal 180 Day Track
S001 1994-11-10 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
00802526489228 P930035 011
00802526605901 P930035 028

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