PMA P860008S021

Device
TAPSCOPE 550
Applicant
Cardio Command
PMA number
P860008
Supplement
S021
Product code
LPA
Decision date
2012-06-05
Classification
System, Esophageal Pacing
Generic name
SYSTEM, ESOPHAGEAL PACING
Approval order statement
APPROVAL OF A NEW SUPPLIER FOR THE MOLDING OF THE PACING WIRE CONNECTOR AND REVISION TO THE MANUFACTURING PROCESS OF THE PACING WIRE ASSEMBLY.

Current openFDA PMA Record#

Device
TAPSCOPE 550
Applicant
Cardio Command
PMA number
P860008
Supplement
S021
Product code
LPA
Generic name
SYSTEM, ESOPHAGEAL PACING
Decision date
2012-06-05
Decision code
APPR
Date received
2012-02-29
Supplement type
135 Review Track For 30-Day Notice
Approval order statement
APPROVAL OF A NEW SUPPLIER FOR THE MOLDING OF THE PACING WIRE CONNECTOR AND REVISION TO THE MANUFACTURING PROCESS OF THE PACING WIRE ASSEMBLY.