PMA P970003S148

Device
VNS THERAPY SYSTEM
Applicant
LivaNova USA, Inc.
PMA number
P970003
Supplement
S148
Product code
MUZ
Decision date
2012-07-23
Classification
Stimulator, Autonomic Nerve, Implanted (depression)
Generic name
Stimulator, autonomic nerve, implanted (depression)
Approval order statement
APPROVAL FOR THE MODEL 250 PROGRAMMING SOFTWARE UPGRADE FROM VERSION 8.0 TO 8.1 AND THE ADDITION OF A NEW COMPACT FLASHCARD.

Current openFDA PMA Record#

Device
VNS THERAPY SYSTEM
Applicant
LivaNova USA, Inc.
PMA number
P970003
Supplement
S148
Product code
MUZ
Generic name
Stimulator, autonomic nerve, implanted (depression)
Decision date
2012-07-23
Decision code
APPR
Date received
2012-05-24
Supplement type
Real-Time Process
Approval order statement
APPROVAL FOR THE MODEL 250 PROGRAMMING SOFTWARE UPGRADE FROM VERSION 8.0 TO 8.1 AND THE ADDITION OF A NEW COMPACT FLASHCARD.