PMA P980016S272
- Device
- VIRTUOSO II/SECURA/MAXIMO II ICDS
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- PMA number
- P980016
- Supplement
- S272
- Product code
- LWS
- Decision date
- 2011-01-19
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- CHANGES TO THE DEVICE RF TEST REQUIREMENTS USED DURING FINAL FUNCTIONAL DEVICE TESTING.
Current openFDA PMA Record#
- Device
- VIRTUOSO II/SECURA/MAXIMO II ICDS
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- PMA number
- P980016
- Supplement
- S272
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2011-01-19
- Decision code
- OK30
- Date received
- 2010-12-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGES TO THE DEVICE RF TEST REQUIREMENTS USED DURING FINAL FUNCTIONAL DEVICE TESTING.