Sweet Tip (R) Rx Steroid Eluting Lead

FDA Premarket Approval P960006 S054

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

Alternate stylet tip forming and inspection manufacturing processes that are performed at the supplier.

DeviceSweet Tip (R) Rx Steroid Eluting Lead
Generic NameDrug Eluting Permanent Right Ventricular (rv) Or Right Atrial (ra) Pacemaker Electrodes
ApplicantBOSTON SCIENTIFIC
Date Received2021-09-30
Decision Date2021-10-04
PMAP960006
SupplementS054
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
S054 2021-09-30 30-day Notice
S053 2021-09-01 30-day Notice
S052 2021-04-30 30-day Notice
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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