PMA P860008S022

Device
ARZCO TRANSESOPHAGEAL CARDIAC STIMULATOR SYSTEM
Applicant
Cardio Command
PMA number
P860008
Supplement
S022
Product code
LPA
Decision date
2012-07-18
Classification
System, Esophageal Pacing
Generic name
SYSTEM, ESOPHAGEAL PACING
Approval order statement
ADDITION OF A NEW PIECE OF EQUIPMENT USED TO CUT AND STRIP PACING WIRES AND SHRINK TUBING.

Current openFDA PMA Record#

Device
ARZCO TRANSESOPHAGEAL CARDIAC STIMULATOR SYSTEM
Applicant
Cardio Command
PMA number
P860008
Supplement
S022
Product code
LPA
Generic name
SYSTEM, ESOPHAGEAL PACING
Decision date
2012-07-18
Decision code
OK30
Date received
2012-06-18
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
ADDITION OF A NEW PIECE OF EQUIPMENT USED TO CUT AND STRIP PACING WIRES AND SHRINK TUBING.