PMA P980016S118
- Device
- VIRTUOSO
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- PMA number
- P980016
- Supplement
- S118
- Product code
- LWS
- Decision date
- 2008-01-03
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- APPROVAL FOR MINOR DESIGN CHANGES THAT ADD ALTERNATE COMPONENTS, DIODES (XD433, XD445) AND CAPACITOR (AVX KYOCERA X5R), TO THE APPROVED DEVICE COMPONENTS FOR USE ON THE HYBRID AS WELL AS MINOR ASSOCIATED MODIFICATIONS TO THE SUBSTRATE. THE DESIGN MODIFICATIONS ARE INTENDED TO INCREASE SUPPLY LINE ROBUSTNESS, REDUCE COMPONENT COSTS, AND IMPROVE INCOMING COMPONENT QUALITY.
Current openFDA PMA Record#
- Device
- VIRTUOSO
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- PMA number
- P980016
- Supplement
- S118
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2008-01-03
- Decision code
- APPR
- Date received
- 2007-12-10
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR MINOR DESIGN CHANGES THAT ADD ALTERNATE COMPONENTS, DIODES (XD433, XD445) AND CAPACITOR (AVX KYOCERA X5R), TO THE APPROVED DEVICE COMPONENTS FOR USE ON THE HYBRID AS WELL AS MINOR ASSOCIATED MODIFICATIONS TO THE SUBSTRATE. THE DESIGN MODIFICATIONS ARE INTENDED TO INCREASE SUPPLY LINE ROBUSTNESS, REDUCE COMPONENT COSTS, AND IMPROVE INCOMING COMPONENT QUALITY.