PMA P860008S023

Device
TAPSCOPE 550 - 200-0010, 200-0025, 250-0010, 250-0025
Applicant
Cardio Command
PMA number
P860008
Supplement
S023
Product code
LPA
Decision date
2017-06-19
Classification
System, Esophageal Pacing
Generic name
SYSTEM, ESOPHAGEAL PACING
Approval order statement
New supplier for the molding of the pacing wire connector.

Current openFDA PMA Record#

Device
TAPSCOPE 550 - 200-0010, 200-0025, 250-0010, 250-0025
Applicant
Cardio Command
PMA number
P860008
Supplement
S023
Product code
LPA
Generic name
SYSTEM, ESOPHAGEAL PACING
Decision date
2017-06-19
Decision code
OK30
Date received
2017-05-16
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
New supplier for the molding of the pacing wire connector.