GZEClass IIIImplant
Implanted Diaphragmatic/phrenic Nerve Stimulator
Neurology · 21 CFR 882.5830
Call for pmas to be filed by 7/7/86 per 51 fr 12101 on 4/8/86
MDR events6All time
Recalls0All time
Registered firms1Currently listed
510(k) clearances0All time
Recent MDR events
6 adverse event reports on file
- IMPLANTED DIAPHRAGMATIC/PHRENIC NERVE STIMULATORAug 11, 2023InjuryAveryMW5123331
- AVERYApr 22, 2009InjuryAvery Biomedical DevicesMW5010852
- MEDTRONIC PHRENIC NERVE PADMay 15, 2002OtherMedtronic Usa, Inc394944
- DOBELLE INSTITUTE PHRENIC NERVE PACEROct 26, 2000InjuryDobel Institute, Inc.MW4002888
- *Apr 13, 1998Death*162738
- *Jun 23, 1997InjuryAtrotechoy99918
Event type breakdown
Injury4
Death1
Other1
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
1 firms currently registered for this product code
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.
PMA approvals
1 premarket approvals for this product code