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 |
| Classification Name | Implanted Diaphragmatic/phrenic Nerve Stimulator |
| Generic Name | Implanted Diaphragmatic/phrenic Nerve Stimulator |
| Applicant | AVERY BIOMEDICAL DEVICES, INC. |
| Date Received | 1989-04-05 |
| Decision Date | 1989-09-29 |
| PMA | P860026 |
| Supplement | S001 |
| Product Code | GZE |
| Advisory Committee | Anesthesiology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | AVERY BIOMEDICAL DEVICES, INC. 61 Mall Dr. commack, NY 11725-5703 |
| 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 |
| Device ID | PMA | Supp |
|---|---|---|
| 00850252006059 | P860026 | 005 |
| 00850252006042 | P860026 | 005 |
| 00850252006035 | P860026 | 005 |
| 00850252006028 | P860026 | 006 |
| 00850252006011 | P860026 | 006 |
| 00850252006004 | P860026 | 008 |
| 00850252006066 | P860026 | 009 |