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 STIMULATOR |
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 | S001 |
Date Received | 04/05/1989 |
Decision Date | 09/29/1989 |
Product Code |
GZE |
Advisory Committee |
Anesthesiology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
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