FDA.reportPublic FDA data

PMA P840002S012

Device
EXTERNAL PULSE GENERATOR MODEL 2A, TAPSCOPE 500 SERIES ESOPHAGEAL STETHOSCOPE AND PACING CATHETER, TAPSCOPE 210 ESOPHAGR
Applicant
Cardiocommand, Inc.
PMA number
P840002
Supplement
S012
Product code
LPA
Decision date
2004-08-27
Classification
System, Esophageal Pacing
Generic name
SYSTEM, ESOPHAGEAL PACING
Approval order statement
APPROVAL FOR THE INTERCHANGEABILITY OF EXISTING APPROVED PRODUCTS. THOSE PRODUCTS ARE EXTERNAL PULSE GENERATORS (MODELS 2A, 7A, AND 7B) AND ESOPHAGEAL CATHETER SYSTEMS (MODELS 205, 210, 210S, 1600, 500 SERIES, AND TAPSUL.)

Current openFDA PMA Record#

Device
EXTERNAL PULSE GENERATOR MODEL 2A, TAPSCOPE 500 SERIES ESOPHAGEAL STETHOSCOPE AND PACING CATHETER, TAPSCOPE 210 ESOPHAGR
Applicant
Cardiocommand, Inc.
PMA number
P840002
Supplement
S012
Product code
LPA
Generic name
SYSTEM, ESOPHAGEAL PACING
Decision date
2004-08-27
Decision code
APPR
Date received
2004-06-04
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
APPROVAL FOR THE INTERCHANGEABILITY OF EXISTING APPROVED PRODUCTS. THOSE PRODUCTS ARE EXTERNAL PULSE GENERATORS (MODELS 2A, 7A, AND 7B) AND ESOPHAGEAL CATHETER SYSTEMS (MODELS 205, 210, 210S, 1600, 500 SERIES, AND TAPSUL.)