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
| Device | DIAPHRAGMATIC PACEMAKER PHRENIC NERVE |
| Classification Name | Implanted Diaphragmatic/phrenic Nerve Stimulator |
| Generic Name | Implanted Diaphragmatic/phrenic Nerve Stimulator |
| Applicant | AVERY BIOMEDICAL DEVICES, INC. |
| Date Received | 2000-04-27 |
| Decision Date | 2000-07-07 |
| PMA | P860026 |
| Supplement | S006 |
| Product Code | GZE |
| Advisory Committee | Anesthesiology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | AVERY BIOMEDICAL DEVICES, INC. 61 Mall Dr. commack, NY 11725-5703 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P860026 | | Original Filing |
| S009 |
2017-09-27 |
Normal 180 Day Track |
| S008 |
2002-09-11 |
Normal 180 Day Track |
| S007 |
2000-11-16 |
Real-time Process |
| S006 |
2000-04-27 |
Normal 180 Day Track |
| S005 |
1995-07-07 |
Normal 180 Day Track |
| S004 |
1993-08-10 |
Normal 180 Day Track |
| S003 |
1991-05-28 |
Normal 180 Day Track |
| S002 |
1990-09-17 |
Normal 180 Day Track |
| S001 |
1989-04-05 |
Normal 180 Day Track |
NIH GUDID Devices