ACUITY STEERABLE LEAD SYSTEM

Drug Eluting Permanent Left Ventricular (lv) Pacemaker Electrode

FDA Premarket Approval P050046 S020

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

Add a new primary supplier of the serial number labels for the defibrillation leads and coronary sinus leads for the devices.

DeviceACUITY STEERABLE LEAD SYSTEM
Classification NameDrug Eluting Permanent Left Ventricular (lv) Pacemaker Electrode
Generic NameDrug Eluting Permanent Left Ventricular (lv) Pacemaker Electrode
ApplicantGUIDANT CORP.
Date Received2013-08-19
Decision Date2013-09-17
PMAP050046
SupplementS020
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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