DIAPHRAGMATIC PACEMAKER PHRENIC NERVE STIMULATOR
FDA premarket approval P860026/S004 · decided 1998-03-03
Approval details
- PMA number
- P860026
- Supplement
- S004
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- DIAPHRAGMATIC PACEMAKER PHRENIC NERVE STIMULATOR
- Generic name
- implanted diaphragmatic/phrenic nerve Stimulator
- Applicant
- Avery Biomedical Devices, Inc.
- Date received
- 1993-08-10
- Decision date
- 1998-03-03
- Days to decision
- 1666 days
- Decision code
- APPR
- Product code
- GZE
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Commack, NY
- 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 suppor
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