PMA P010031S909

Device: Amplia MRI CRT-D; Amplia MRI Quad CRT-D; Brava CRT-D; Brava Quad CRT-D; Claria MRI CRT-D; Claria MRI Quad CRT-D; Cobalt
Applicant: Medtronic Cardiac Rhythm Disease Management
PMA number: P010031
Supplement: S909
Product code: NIK
Decision date: 2025-12-15
Classification: Cardiovascular
Generic name: Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
Approval order statement: updates to the incoming inspection procedure for interconnect ribbon components

Current openFDA PMA Record#

Device: Amplia MRI CRT-D; Amplia MRI Quad CRT-D; Brava CRT-D; Brava Quad CRT-D; Claria MRI CRT-D; Claria MRI Quad CRT-D; Cobalt
Applicant: Medtronic Cardiac Rhythm Disease Management
PMA number: P010031
Supplement: S909
Product code: NIK
Generic name: Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
Decision date: 2025-12-15
Decision code: OK30
Date received: 2025-11-13
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: updates to the incoming inspection procedure for interconnect ribbon components