SWEET TIP Rx, SWEET PICOTIO Rx, and FLEXTEND

FDA Premarket Approval P960006 S051

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

DeviceSWEET TIP Rx, SWEET PICOTIO Rx, and FLEXTEND
Generic NameDrug Eluting Permanent Right Ventricular (rv) Or Right Atrial (ra) Pacemaker Electrodes
ApplicantBOSTON SCIENTIFIC
Date Received2021-03-08
Decision Date2021-04-02
PMAP960006
SupplementS051
Product CodeNVN 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product Yes
Applicant Address BOSTON SCIENTIFIC 4100 Hamline Avenue North st. Paul, MN 55112

Supplemental Filings

Supplement NumberDateSupplement Type
P960006Original Filing
S051 2021-03-08 30-day Notice
S050 2021-01-11 30-day Notice
S049 2019-03-13 30-day Notice
S048 2018-07-13 30-day Notice
S047 2018-03-26 30-day Notice
S046 2016-05-27 30-day Notice
S045
S044 2015-06-22 30-day Notice
S043 2014-06-30 30-day Notice
S042 2014-04-22 30-day Notice
S041 2014-01-28 Real-time Process
S040 2013-08-29 30-day Notice
S039 2013-05-16 Real-time Process
S038 2013-03-19 Real-time Process
S037 2012-11-08 30-day Notice
S036 2012-10-02 30-day Notice
S035 2012-09-04 30-day Notice
S034 2012-06-19 30-day Notice
S033 2012-03-26 30-day Notice
S032 2012-01-24 30-day Notice
S031 2011-05-25 30-day Notice
S030 2011-04-01 30-day Notice
S029 2010-12-01 135 Review Track For 30-day Notice
S028
S027 2010-09-21 30-day Notice
S026 2009-12-18 30-day Notice
S025 2009-12-16 30-day Notice
S024
S023
S022 2007-05-07 30-day Notice
S021 2006-04-13 30-day Notice
S020 2006-04-13 30-day Notice
S019 2005-11-09 30-day Notice
S018
S017 2005-08-01 30-day Notice
S016 2005-07-05 30-day Notice
S015 2005-04-13 30-day Notice
S014 2005-02-24 30-day Notice
S013 2004-12-03 30-day Notice
S012 2004-10-21 30-day Notice
S011
S010 2004-04-14 30-day Notice
S009 2004-01-13 30-day Notice
S008 2003-03-20 Real-time Process
S007 2002-11-13 30-day Notice
S006
S005 2001-07-11 Normal 180 Day Track
S004 2000-08-21 Normal 180 Day Track
S003 1999-12-16 Normal 180 Day Track
S002 1998-10-29 Real-time Process
S001 1998-10-02 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
00802526489419 P960006 005
00802526397745 P960006 015
00802526397738 P960006 015
00802526397721 P960006 015
00802526064043 P960006 039

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