PMA P010031S808

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: S808
Product code: NIK
Decision date: 2022-11-22
Generic name: Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
Approval order statement: Relocation of the Chemical Operations area within the same manufacturing facility (Medtronic Energy and Component Center) for selected 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: S808
Product code: NIK
Generic name: Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
Decision date: 2022-11-22
Decision code: OK30
Date received: 2022-11-16
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Relocation of the Chemical Operations area within the same manufacturing facility (Medtronic Energy and Component Center) for selected components.