PMA P980016S462
- Device
- EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- PMA number
- P980016
- Supplement
- S462
- Product code
- LWS
- Decision date
- 2014-02-27
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- ADD AN ADDITIONAL INCOMING INSPECTION TEST OF THE RAW MATERIAL USED TO MANUFACTURE THE CAPACITOR FEED THROUGH DEFORMATION ELEMENTS FOR THE DEVICES.
Current openFDA PMA Record#
- Device
- EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- PMA number
- P980016
- Supplement
- S462
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2014-02-27
- Decision code
- OK30
- Date received
- 2014-01-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADD AN ADDITIONAL INCOMING INSPECTION TEST OF THE RAW MATERIAL USED TO MANUFACTURE THE CAPACITOR FEED THROUGH DEFORMATION ELEMENTS FOR THE DEVICES.