- Device
- Amplia MRI CRTD-D,Amplia MRI Quad CRT-D,Brava CRT-D,Brava Quad CRT-D,Claria MRI CRT-D,Claria MRI Quad CRT-D,Cobalt MRI C
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- PMA number
- P010031
- Supplement
- S702
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2020-06-08
- Decision code
- OK30
- Date received
- 2020-05-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modify final visual inspection requirements for hybrid modules.