STAT-PACE II ESOPHAGEAL PACING SYSTEM

System, Esophageal Pacing

FDA Premarket Approval P840002 S009

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 for design and labeling modification to the tapsystem 2a and the stat-pace ii esophageal pacing systems.

DeviceSTAT-PACE II ESOPHAGEAL PACING SYSTEM
Classification NameSystem, Esophageal Pacing
Generic NameSystem, Esophageal Pacing
ApplicantCARDIOCOMMAND, INC.
Date Received1997-01-21
Decision Date1997-09-03
PMAP840002
SupplementS009
Product CodeLPA
Advisory CommitteeCardiovascular
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address CARDIOCOMMAND, INC. 4920 West Cypress Street suite 110 tampa, FL 33607-3837

Supplemental Filings

Supplement NumberDateSupplement Type
P840002Original Filing
S013 2015-05-28 Normal 180 Day Track No User Fee
S012 2004-06-04 Real-time Process
S011 2004-03-09 Normal 180 Day Track No User Fee
S010 2004-01-16 Normal 180 Day Track No User Fee
S009 1997-01-21 Normal 180 Day Track
S008 1996-01-03 Normal 180 Day Track
S007 1995-10-02 Normal 180 Day Track
S006
S005
S004
S003
S002
S001 1993-07-12 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
00856233005073 P840002 000
00856233005158 P840002 007
00856233005066 P840002 007
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