SELUTE(R) STEROID-ELUTING LEAD

FDA Premarket Approval P950001 S005

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

Approval is for the use of a modified suture sleeve.

DeviceSELUTE(R) STEROID-ELUTING LEAD
Generic NamePermanent Pacemaker Electrode
ApplicantBOSTON SCIENTIFIC
Date Received1999-12-16
Decision Date2000-03-10
PMAP950001
SupplementS005
Product CodeDTB 
Advisory CommitteeCardiovascular
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address BOSTON SCIENTIFIC 4100 Hamline Avenue North st. Paul, MN 55112

Supplemental Filings

Supplement NumberDateSupplement Type
P950001Original Filing
S029 2021-03-08 30-day Notice
S028 2016-05-27 30-day Notice
S027 2014-06-30 30-day Notice
S026 2013-08-29 30-day Notice
S025 2012-11-08 30-day Notice
S024 2012-10-02 30-day Notice
S023 2012-03-26 30-day Notice
S022 2011-04-01 30-day Notice
S021 2009-12-18 30-day Notice
S020 2009-12-16 30-day Notice
S019
S018
S017 2006-04-13 30-day Notice
S016 2006-04-13 30-day Notice
S015 2005-10-06 Real-time Process
S014 2005-02-24 30-day Notice
S013 2004-12-03 30-day Notice
S012 2004-10-21 30-day Notice
S011 2004-04-14 30-day Notice
S010 2004-01-13 30-day Notice
S009 2002-11-13 30-day Notice
S008 2000-08-21 Normal 180 Day Track
S007 2000-05-31 Real-time Process
S006 2000-04-17 Real-time Process
S005 1999-12-16 Normal 180 Day Track
S004 1999-11-15 Normal 180 Day Track
S003 1997-10-01 Normal 180 Day Track
S002 1997-04-03 Normal 180 Day Track
S001 1996-10-16 Normal 180 Day Track

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