SELUTE Lead System

FDA Premarket Approval P950001 S029

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

DeviceSELUTE Lead System
Generic NameDrug Eluting Permanent Right Ventricular (rv) Or Right Atrial (ra) Pacemaker Electrodes
ApplicantBOSTON SCIENTIFIC
Date Received2021-03-08
Decision Date2021-04-02
PMAP950001
SupplementS029
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
P950001Original Filing
S029 2021-03-08 30-day Notice
S028 0000-00-00
S027 0000-00-00
S026 0000-00-00
S025 0000-00-00
S024 2012-10-02 30-day Notice
S023 0000-00-00
S022 0000-00-00
S021 0000-00-00
S020 0000-00-00
S019
S018
S017
S016
S015
S014
S013
S012
S011
S010
S009
S008 0000-00-00
S007 0000-00-00
S006 2000-04-17 Real-time Process
S005 0000-00-00
S004 0000-00-00
S003 0000-00-00
S002 0000-00-00
S001 0000-00-00

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