DIAPHAGMATIC/PHRENIC NERVE STIMULATOR
FDA premarket approval P860026/S007 · decided 2001-01-26
Approval details
- PMA number
- P860026
- Supplement
- S007
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- DIAPHAGMATIC/PHRENIC NERVE STIMULATOR
- Generic name
- implanted diaphragmatic/phrenic nerve Stimulator
- Applicant
- Avery Biomedical Devices, Inc.
- Date received
- 2000-11-16
- Decision date
- 2001-01-26
- Days to decision
- 71 days
- Decision code
- APPR
- Product code
- GZE
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Commack, NY
- Statement
- APPROVAL FOR CHANGING THE METHOD OF ATTACHING THE BATTERY CONNECTOR AND WIRING FROM THE POWER SWITCHES TO THE PRINTED CIRCUIT BOARD, CHANGING THE POINT WHERE THE SIGNAL IS TAKEN TO ILLUMINATE THE BATTERY LED INDICATOR, ADDING THE ENERGY SOURCE ROUTING TO THE FRONT PANEL OF THE RESPIRATORY RATE CONTROL CIRCUITRY, CHANGING THE POINT WHEE THE BATTERY POWER IS OBTAINED FOR EACH STIMULATOR OUTPUT AMPLIFIER CIRCUIT, AND DECREASING THE SENSITIVITY OF THE OSCILLATOR CIRCUIT TO TRANSISTOR OUTPUT CAPACITA
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