PMA P980016S523
- Device
- EVERA S DR, VR,; EVERA XT DR, EVERA XT VR , MAXIMO II , PROTECTA , PROTECTA XT, SECURA; AND VIRTUOSO II D/RVR ICD'S
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- PMA number
- P980016
- Supplement
- S523
- Product code
- LWS
- Decision date
- 2015-02-23
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- ADD AN ADDITIONAL SUPPLIER FOR TANTALUM SUBSTRATES FOR CAPACITORS USED IN THE DEVICES.
Current openFDA PMA Record#
- Device
- EVERA S DR, VR,; EVERA XT DR, EVERA XT VR , MAXIMO II , PROTECTA , PROTECTA XT, SECURA; AND VIRTUOSO II D/RVR ICD'S
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- PMA number
- P980016
- Supplement
- S523
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2015-02-23
- Decision code
- OK30
- Date received
- 2015-01-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADD AN ADDITIONAL SUPPLIER FOR TANTALUM SUBSTRATES FOR CAPACITORS USED IN THE DEVICES.