PMA P970003S033

Device: NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM
Applicant: LivaNova USA, Inc.
PMA number: P970003
Supplement: S033
Product code: LYJ
Decision date: 2001-06-07
Classification: Stimulator, Autonomic Nerve, Implanted For Epilepsy
Generic name: Stimulator, autonomic nerve, implanted for epilepsy
Approval order statement: APPROVAL FOR LABELING CHANGES. THE CHANGES ARE INTENDED TO: 1) ADD A WARNING THAT RECOMMENDS THAT PHYSICIANS USE CARE WHEN TREATING PATIENTS WITH PRE-EXISTING OBSTRUCTIVE SLEEP APNEA (OSA), AND 2) ADD AND STRENGTHEN PRECAUTIONS REGARDING: A) ELECTROSURGERY, B) THERAPEUTIC ULTRASOUND, C) EXPOSURE TO ENVIRONMENTS THAT ARE PROTECTED BY A WARNING NOTICE PREVENTING ENTRY BY PATIENTS WITH AN IMPLANTED PACEMAKER, AND D) APPLICATION OF OTHER THERAPIES INVOLVING ELECTRIC CURRENT, SUCH AS TENS DEVICES.

Current openFDA PMA Record#

Device: NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM
Applicant: LivaNova USA, Inc.
PMA number: P970003
Supplement: S033
Product code: LYJ
Generic name: Stimulator, autonomic nerve, implanted for epilepsy
Decision date: 2001-06-07
Decision code: APPR
Date received: 2001-05-07
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR LABELING CHANGES. THE CHANGES ARE INTENDED TO: 1) ADD A WARNING THAT RECOMMENDS THAT PHYSICIANS USE CARE WHEN TREATING PATIENTS WITH PRE-EXISTING OBSTRUCTIVE SLEEP APNEA (OSA), AND 2) ADD AND STRENGTHEN PRECAUTIONS REGARDING: A) ELECTROSURGERY, B) THERAPEUTIC ULTRASOUND, C) EXPOSURE TO ENVIRONMENTS THAT ARE PROTECTED BY A WARNING NOTICE PREVENTING ENTRY BY PATIENTS WITH AN IMPLANTED PACEMAKER, AND D) APPLICATION OF OTHER THERAPIES INVOLVING ELECTRIC CURRENT, SUCH AS TENS DEVICES.