ARZCO TRANSESOPHAGEAL CARDIAC STIMULATOR SYSTEM

System, Esophageal Pacing

FDA Premarket Approval P860008 S022

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

Addition of a new piece of equipment used to cut and strip pacing wires and shrink tubing.

DeviceARZCO TRANSESOPHAGEAL CARDIAC STIMULATOR SYSTEM
Classification NameSystem, Esophageal Pacing
Generic NameSystem, Esophageal Pacing
ApplicantCARDIO COMMAND
Date Received2012-06-18
Decision Date2012-07-18
PMAP860008
SupplementS022
Product CodeLPA
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address CARDIO COMMAND 4920 West Cypress St. Ste.110 tampa, FL 33607

Supplemental Filings

Supplement NumberDateSupplement Type
P860008Original Filing
S023 2017-05-16 30-day Notice
S022 2012-06-18 30-day Notice
S021 2012-02-29 135 Review Track For 30-day Notice
S020 2011-10-24 135 Review Track For 30-day Notice
S019 2009-07-06 Special (immediate Track)
S018 2004-06-04 Real-time Process
S017 2004-01-16 Normal 180 Day Track No User Fee
S016 1998-05-19 Real-time Process
S015
S014
S013
S012
S011 1991-06-20 Normal 180 Day Track
S010 1991-02-20 Normal 180 Day Track
S009 1990-04-12 Normal 180 Day Track
S008 1989-10-17 Normal 180 Day Track
S007 1989-03-16 Normal 180 Day Track
S006
S005 1988-12-12 Normal 180 Day Track
S004
S003 1988-07-05 Special (immediate Track)
S002 1988-05-13 Special (immediate Track)
S001 1987-08-05 Panel Track

NIH GUDID Devices

Device IDPMASupp
00856233005141 P860008 000
00856233005028 P860008 017
00856233005035 P860008 017
00856233005042 P860008 017
00856233005080 P860008 017
00856233005196 P860008 018
00856233005011 P860008 018
00856233005103 P860008 018
00856233005110 P860008 018
00856233005127 P860008 018
00856233005134 P860008 018
00856233005165 P860008 018
00856233005172 P860008 018
00856233005189 P860008 018
00856233005004 P860008 018

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