PMA P860026S006

Device: DIAPHRAGMATIC PACEMAKER PHRENIC NERVE
Applicant: Avery Biomedical Devices, Inc.
PMA number: P860026
Supplement: S006
Product code: GZE
Decision date: 2000-07-07
Classification: Implanted Diaphragmatic/phrenic Nerve Stimulator
Generic name: implanted diaphragmatic/phrenic nerve Stimulator
Approval order statement: APPROVAL FOR PROCESS VALIDATION OF THE PROPOSED DEVICE STERILIZATION PROCEDURE, PROPOSED LABELING FOR THE DEVICE PACKAGING, AND THE PROPOSED CHANGES TO THE INSTRUCTION MANUAL. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MARK IV AND IS INDICATED FOR PERSONS WHO REQUIRE CHRONIC VENTILATORY SUPPORT BECAUSE OOF UPPER MOTOR NEURON RESPIRATORY MUSCLE PARALYSIS (RMP) OR BECAUSE OF CENTRAL ALVEOLAR HYPOVENTILATION (CAH) AND WHOSE REMAINING PHRENIC NERVE, LUNG, AND DIAPHRAGM FUNCTION

Current openFDA PMA Record#

Device: DIAPHRAGMATIC PACEMAKER PHRENIC NERVE
Applicant: Avery Biomedical Devices, Inc.
PMA number: P860026
Supplement: S006
Product code: GZE
Generic name: implanted diaphragmatic/phrenic nerve Stimulator
Decision date: 2000-07-07
Decision code: APPR
Date received: 2000-04-27
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR PROCESS VALIDATION OF THE PROPOSED DEVICE STERILIZATION PROCEDURE, PROPOSED LABELING FOR THE DEVICE PACKAGING, AND THE PROPOSED CHANGES TO THE INSTRUCTION MANUAL. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MARK IV AND IS INDICATED FOR PERSONS WHO REQUIRE CHRONIC VENTILATORY SUPPORT BECAUSE OOF UPPER MOTOR NEURON RESPIRATORY MUSCLE PARALYSIS (RMP) OR BECAUSE OF CENTRAL ALVEOLAR HYPOVENTILATION (CAH) AND WHOSE REMAINING PHRENIC NERVE, LUNG, AND DIAPHRAGM FUNCTION