PMA P970003S222

Device: VNS Therapy System
Applicant: LivaNova USA, Inc.
PMA number: P970003
Supplement: S222
Product code: LYJ
Decision date: 2019-02-14
Classification: Stimulator, Autonomic Nerve, Implanted For Epilepsy
Generic name: Stimulator, autonomic nerve, implanted for epilepsy
Approval order statement: Approval for the following labeling updates:1) Model 1000 (SN < 100,000) High Impedance Warning - the addition of a warning to the VNS Therapy Physicians Manuals for both Epilepsy and Depression regarding the potential for erroneous high impedance warning messages that can be received in certain Model 1000 Generators (i.e. Serial Number (SN) < 100,000); and2) Model 1000 (SN < 100,000) Package Insert: the creation of a package insert, containing the same warning information described above, that will be placed within the sales packaging of every Model 1000 Generator (SN < 100,000).

Current openFDA PMA Record#

Device: VNS Therapy System
Applicant: LivaNova USA, Inc.
PMA number: P970003
Supplement: S222
Product code: LYJ
Generic name: Stimulator, autonomic nerve, implanted for epilepsy
Decision date: 2019-02-14
Decision code: APPR
Date received: 2019-01-15
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for the following labeling updates:1) Model 1000 (SN < 100,000) High Impedance Warning - the addition of a warning to the VNS Therapy Physicians Manuals for both Epilepsy and Depression regarding the potential for erroneous high impedance warning messages that can be received in certain Model 1000 Generators (i.e. Serial Number (SN) < 100,000); and2) Model 1000 (SN < 100,000) Package Insert: the creation of a package insert, containing the same warning information described above, that will be placed within the sales packaging of every Model 1000 Generator (SN < 100,000).