PMA P860026S009
- Device
- Avery Diaphragm Pacing System (alson known as Breathing Pacemaker System)
- Applicant
- Avery Biomedical Devices, Inc.
- PMA number
- P860026
- Supplement
- S009
- Product code
- GZE
- Decision date
- 2019-11-04
- Classification
- Implanted Diaphragmatic/phrenic Nerve Stimulator
- Generic name
- implanted diaphragmatic/phrenic nerve Stimulator
- Approval order statement
- Approval to replace the Mark IV transmitter with the digital Spirit transmitter.
Current openFDA PMA Record#
- Device
- Avery Diaphragm Pacing System (alson known as Breathing Pacemaker System)
- Applicant
- Avery Biomedical Devices, Inc.
- PMA number
- P860026
- Supplement
- S009
- Product code
- GZE
- Generic name
- implanted diaphragmatic/phrenic nerve Stimulator
- Decision date
- 2019-11-04
- Decision code
- APPR
- Date received
- 2017-09-27
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval to replace the Mark IV transmitter with the digital Spirit transmitter.