PMA P860026S008
- Device
- DIAPHRAGMATIC PACEMAKER PHRENIC NERVE STIMULATOR
- Applicant
- Avery Biomedical Devices, Inc.
- PMA number
- P860026
- Supplement
- S008
- Product code
- GZE
- Decision date
- 2003-03-03
- Classification
- Implanted Diaphragmatic/phrenic Nerve Stimulator
- Generic name
- implanted diaphragmatic/phrenic nerve Stimulator
- Approval order statement
- APPROVAL FOR SELECTING A FINAL VALUE OF C22 AND C50 CAPACITORS DURING PRODUCTION TESTING BASED ON PARAMETERS MEASURED WITH CALIBRATED TEST EQUIPMENT TO RESULT IN PEAK OPERATING PERFORMANCE OF THE TRANSMITTER.
Current openFDA PMA Record#
- Device
- DIAPHRAGMATIC PACEMAKER PHRENIC NERVE STIMULATOR
- Applicant
- Avery Biomedical Devices, Inc.
- PMA number
- P860026
- Supplement
- S008
- Product code
- GZE
- Generic name
- implanted diaphragmatic/phrenic nerve Stimulator
- Decision date
- 2003-03-03
- Decision code
- APPR
- Date received
- 2002-09-11
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR SELECTING A FINAL VALUE OF C22 AND C50 CAPACITORS DURING PRODUCTION TESTING BASED ON PARAMETERS MEASURED WITH CALIBRATED TEST EQUIPMENT TO RESULT IN PEAK OPERATING PERFORMANCE OF THE TRANSMITTER.