PMA P970003S046

Device: NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM
Applicant: LivaNova USA, Inc.
PMA number: P970003
Supplement: S046
Product code: LYJ
Decision date: 2003-09-30
Classification: Stimulator, Autonomic Nerve, Implanted For Epilepsy
Generic name: Stimulator, autonomic nerve, implanted for epilepsy
Approval order statement: APPROVAL FOR AN ALTERNATIVE STERILIZATION PROCESS (HYDROGEN PEROXIDE GAS PLASMA USING THE STERRAD 200 GMP STERILIZER) FOR THE MODEL 401 TUNNELER AND APPROVAL OF A PROTOCOL FOR B1 INCUBATION REDUCTION AND SHELF LIFE STUDY, AS WELL AS A NEW STERILIZATION FACILITY (CYBERONICS, INC., HOUSTON, TEXAS).

Current openFDA PMA Record#

Device: NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM
Applicant: LivaNova USA, Inc.
PMA number: P970003
Supplement: S046
Product code: LYJ
Generic name: Stimulator, autonomic nerve, implanted for epilepsy
Decision date: 2003-09-30
Decision code: APPR
Date received: 2002-11-29
Supplement type: Normal 180 Day Track
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR AN ALTERNATIVE STERILIZATION PROCESS (HYDROGEN PEROXIDE GAS PLASMA USING THE STERRAD 200 GMP STERILIZER) FOR THE MODEL 401 TUNNELER AND APPROVAL OF A PROTOCOL FOR B1 INCUBATION REDUCTION AND SHELF LIFE STUDY, AS WELL AS A NEW STERILIZATION FACILITY (CYBERONICS, INC., HOUSTON, TEXAS).