PMA P970003S167

Device
MODEL 201 PROGRAMMING WAND
Applicant
LivaNova USA, Inc.
PMA number
P970003
Supplement
S167
Product code
MUZ
Decision date
2014-01-02
Classification
Stimulator, Autonomic Nerve, Implanted (depression)
Generic name
Stimulator, autonomic nerve, implanted (depression)
Approval order statement
REPLACE THE CAPACITOR USED IN THE ASSEMBLY OF THE PRINTED CIRCUIT BOARDS FOR THE PROGRAMMING WAND.

Current openFDA PMA Record#

Device
MODEL 201 PROGRAMMING WAND
Applicant
LivaNova USA, Inc.
PMA number
P970003
Supplement
S167
Product code
MUZ
Generic name
Stimulator, autonomic nerve, implanted (depression)
Decision date
2014-01-02
Decision code
OK30
Date received
2013-12-03
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
REPLACE THE CAPACITOR USED IN THE ASSEMBLY OF THE PRINTED CIRCUIT BOARDS FOR THE PROGRAMMING WAND.