DIAPHRAGMATIC PACEMAKER PHRENIC NERVE STIMULATOR
FDA premarket approval P860026/S001 · decided 1989-09-29
Approval details
- PMA number
- P860026
- Supplement
- S001
- 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
- 1989-04-05
- Decision date
- 1989-09-29
- Days to decision
- 177 days
- Decision code
- APPR
- Product code
- GZE
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Commack, NY
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