Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | DIAPHRAGMATIC PACEMAKER PHRENIC NERVE |
Generic Name | implanted diaphragmatic/phrenic nerve Stimulator |
Regulation Number | 882.5830 |
Applicant | AVERY BIOMEDICAL DEVICES, INC. 61 MALL DR. COMMACK, NY 11725-5703 |
PMA Number | P860026 |
Supplement Number | S006 |
Date Received | 04/27/2000 |
Decision Date | 07/07/2000 |
Product Code |
GZE |
Advisory Committee |
Anesthesiology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
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 |
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