| 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. |
| |
| 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 | S004 |
|---|
| Date Received | 08/10/1993 |
|---|
| Decision Date | 03/03/1998 |
|---|
| 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 |
|---|
Approval Order Statement
Approval for bilateral stimulus output redundancy, external breathing rate control, antenna indicators which verify stimulus output and antenna integrity, concealed factory controls, additional covering to the battery connector, and design improvements to existing architecture that do no increase stimulus parameters above what was approved on January 5, 1987. The device, as modified, will be marketed under the trade name mark IV and is indicated for persons who require chronic ventilatory support because of upper motor neuron respiratory muscle paralysis (RMP) or because of contral alveolar hypoventilation (CAH) and whose remaining phrenic nerve, lung, and diaphragm functions is sufficient ota ccommodate electrical stimulation. |
|
|
