PMA P980016S495
- Device
- EVERA S DR ICD, EVERA S VR ICS, EVERA XT DR ICD, EVERA XT VR ICD, MAXIMO 11 ICD, PROTECTA ICD, SECURA ICD, VIRTUOSO II D
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- PMA number
- P980016
- Supplement
- S495
- Product code
- LWS
- Decision date
- 2014-08-13
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- USE A NEW SOFTWARE VERSION TO COLLECT MEASUREMENT AND PROCESS DATA AT THE HYBRID SUPPLIER.
Current openFDA PMA Record#
- Device
- EVERA S DR ICD, EVERA S VR ICS, EVERA XT DR ICD, EVERA XT VR ICD, MAXIMO 11 ICD, PROTECTA ICD, SECURA ICD, VIRTUOSO II D
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- PMA number
- P980016
- Supplement
- S495
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2014-08-13
- Decision code
- OK30
- Date received
- 2014-08-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- USE A NEW SOFTWARE VERSION TO COLLECT MEASUREMENT AND PROCESS DATA AT THE HYBRID SUPPLIER.