PMA P980016S193
- Device
- SECURA DR/VR/MAXIMO II DR/VR/VIRTUOSO II DR/VR
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- PMA number
- P980016
- Supplement
- S193
- Product code
- LWS
- Decision date
- 2009-05-08
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- CHANGES TO THE DEVICE FUNCTIONAL TEST SOFTWARE.
Current openFDA PMA Record#
- Device
- SECURA DR/VR/MAXIMO II DR/VR/VIRTUOSO II DR/VR
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- PMA number
- P980016
- Supplement
- S193
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2009-05-08
- Decision code
- OK30
- Date received
- 2009-04-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGES TO THE DEVICE FUNCTIONAL TEST SOFTWARE.