PMA P970003S019

Device
NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM
Applicant
LivaNova USA, Inc.
PMA number
P970003
Supplement
S019
Product code
LYJ
Decision date
1999-04-05
Classification
Stimulator, Autonomic Nerve, Implanted For Epilepsy
Generic name
Stimulator, autonomic nerve, implanted for epilepsy
Approval order statement
The 30-Day Notice requested relocation of the Seam Welding Equipment from the Webster, Texas manufacturing facility to the existing Houston, Texas (Space Center) manufacturing facility.

Current openFDA PMA Record#

Device
NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM
Applicant
LivaNova USA, Inc.
PMA number
P970003
Supplement
S019
Product code
LYJ
Generic name
Stimulator, autonomic nerve, implanted for epilepsy
Decision date
1999-04-05
Decision code
OK30
Date received
1999-03-19
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
The 30-Day Notice requested relocation of the Seam Welding Equipment from the Webster, Texas manufacturing facility to the existing Houston, Texas (Space Center) manufacturing facility.