PMA P980016S362
- Device
- MAXIMO II DF4 ICD, SECURA DF4 ICD
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- PMA number
- P980016
- Supplement
- S362
- Product code
- LWS
- Decision date
- 2012-09-12
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- APPROVAL FOR THE USE OF RECENTLY APPROVED SOFTWARE 9995 VERSION 7.4 AND ASSOCIATED DDMA SOFTWARE 2491 WITH RECENTLY APPROVED DEVICE MODELS D264VRM AND D204VRM.
Current openFDA PMA Record#
- Device
- MAXIMO II DF4 ICD, SECURA DF4 ICD
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- PMA number
- P980016
- Supplement
- S362
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2012-09-12
- Decision code
- APPR
- Date received
- 2012-06-14
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE USE OF RECENTLY APPROVED SOFTWARE 9995 VERSION 7.4 AND ASSOCIATED DDMA SOFTWARE 2491 WITH RECENTLY APPROVED DEVICE MODELS D264VRM AND D204VRM.