ACUITY STEERABLE LEAD SYSTEM

FDA Premarket Approval P050046 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

To use a new controlled environment area at the boston scientific dorado, puerto rico facility

DeviceACUITY STEERABLE LEAD SYSTEM
Generic NameDrug Eluting Permanent Left Ventricular (lv) Pacemaker Electrode
ApplicantGUIDANT CORP.
Date Received2021-09-01
Decision Date2021-09-24
PMAP050046
SupplementS032
Product CodeOJX 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product Yes
Applicant Address GUIDANT CORP. 4100 Hamline Avenue North st. Paul, MN 55112-5798

Supplemental Filings

Supplement NumberDateSupplement Type
P050046Original Filing
S032 2021-09-01 30-day Notice
S031 2021-03-08 30-day Notice
S030 2021-01-11 30-day Notice
S029 2018-07-13 30-day Notice
S028 2018-03-26 30-day Notice
S027
S026 2015-06-22 30-day Notice
S025 2015-06-05 30-day Notice
S024 2014-07-25 30-day Notice
S023 2014-01-28 Real-time Process
S022 2013-11-18 30-day Notice
S021 2013-08-29 30-day Notice
S020 2013-08-19 30-day Notice
S019 2012-11-14 Real-time Process
S018 2012-11-08 30-day Notice
S017 2012-10-02 30-day Notice
S016 2012-09-04 30-day Notice
S015 2012-07-30 30-day Notice
S014 2012-03-26 30-day Notice
S013 2012-01-24 30-day Notice
S012 2011-12-02 Real-time Process
S011 2011-05-25 30-day Notice
S010 2011-04-01 30-day Notice
S009 2011-01-26 135 Review Track For 30-day Notice
S008
S007 2010-08-23 30-day Notice
S006 2009-12-18 30-day Notice
S005 2009-12-16 30-day Notice
S004 2009-02-04 135 Review Track For 30-day Notice
S003 2008-08-01 30-day Notice
S002 2007-11-23 Real-time Process
S001

NIH GUDID Devices

Device IDPMASupp
00802526419447 P050046 000
00802526419324 P050046 000

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