PMA P010031S088
- Device
- CONCERTO
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- PMA number
- P010031
- Supplement
- S088
- Product code
- NIK
- Decision date
- 2008-01-03
- Classification
- Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (crt-d)
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- 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
- CONCERTO
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- PMA number
- P010031
- Supplement
- S088
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- 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.