PMA P010031S568
- Device
- Claria MRI CRT-D QUAD SureScan; Amplia MRI Quad CRT-D SureScan; Compia MRI CRT-D SureScan
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- PMA number
- P010031
- Supplement
- S568
- Product code
- NIK
- Decision date
- 2016-11-23
- Classification
- Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (crt-d)
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Approval order statement
- Iimplementation of a number of manufacturing changes previously approved for other Medtronic products.
Current openFDA PMA Record#
- Device
- Claria MRI CRT-D QUAD SureScan; Amplia MRI Quad CRT-D SureScan; Compia MRI CRT-D SureScan
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- PMA number
- P010031
- Supplement
- S568
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2016-11-23
- Decision code
- OK30
- Date received
- 2016-10-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Iimplementation of a number of manufacturing changes previously approved for other Medtronic products.