PMA P970003S051

Device: NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM
Applicant: LivaNova USA, Inc.
PMA number: P970003
Supplement: S051
Product code: LYJ
Decision date: 2004-04-29
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 302 LEAD AND MODEL 502 ACCESSORY PACK AND APPROVAL FOR A THREE YEAR SHELF LIFE FOR THE MODEL 302 LEAD AND MODEL 502 ACCESSORY PACK.

Current openFDA PMA Record#

Device: NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM
Applicant: LivaNova USA, Inc.
PMA number: P970003
Supplement: S051
Product code: LYJ
Generic name: Stimulator, autonomic nerve, implanted for epilepsy
Decision date: 2004-04-29
Decision code: APPR
Date received: 2004-02-24
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 302 LEAD AND MODEL 502 ACCESSORY PACK AND APPROVAL FOR A THREE YEAR SHELF LIFE FOR THE MODEL 302 LEAD AND MODEL 502 ACCESSORY PACK.