STAT PACE II

System, Esophageal Pacing

FDA Premarket Approval P840002 S011

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 manufacturing sites located at martech medical products, baja california, mexico and harleysville, pennsylvania.

DeviceSTAT PACE II
Classification NameSystem, Esophageal Pacing
Generic NameSystem, Esophageal Pacing
ApplicantCARDIOCOMMAND, INC.
Date Received2004-03-09
Decision Date2004-10-01
PMAP840002
SupplementS011
Product CodeLPA
Advisory CommitteeCardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonExpress Gmp Supplement
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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