PMA P980016S216
- Device
- MEDTRONIC SECURA DR D204DRM, MAXIMO II D264DRM, IMPLANTABLE CARDIOVERTER DEFIBRILLATORS
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- PMA number
- P980016
- Supplement
- S216
- Product code
- LWS
- Decision date
- 2012-01-09
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- APPROVAL FOR THE DF4 CONNECTOR SYSTEM, WHICH IS COMPRISED OF THE ICD, CRT-D AND DEFIBRILLATION LEAD DEVICES FOR THE DEVICES.
Current openFDA PMA Record#
- Device
- MEDTRONIC SECURA DR D204DRM, MAXIMO II D264DRM, IMPLANTABLE CARDIOVERTER DEFIBRILLATORS
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- PMA number
- P980016
- Supplement
- S216
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2012-01-09
- Decision code
- APPR
- Date received
- 2009-12-04
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE DF4 CONNECTOR SYSTEM, WHICH IS COMPRISED OF THE ICD, CRT-D AND DEFIBRILLATION LEAD DEVICES FOR THE DEVICES.