PMA P010031S927

Device: Amplia MRI CRT-D DTMB1D1, DTMB1D4; Amplia MRI Quad CRTD DTMB1Q1, DTMB1QQ; Brava CRT-D DTBC1D1, DTBC1D4; Brava Quad CRT-D
Applicant: Medtronic Cardiac Rhythm Disease Management
PMA number: P010031
Supplement: S927
Product code: NIK
Decision date: 2026-07-22
Classification: Cardiovascular
Generic name: Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
Approval order statement: implementing an automated vision inspection system and supporting manufacturing process controls for antenna alignment verification during connector module assembly

Current openFDA PMA Record#

Device: Amplia MRI CRT-D DTMB1D1, DTMB1D4; Amplia MRI Quad CRTD DTMB1Q1, DTMB1QQ; Brava CRT-D DTBC1D1, DTBC1D4; Brava Quad CRT-D
Applicant: Medtronic Cardiac Rhythm Disease Management
PMA number: P010031
Supplement: S927
Product code: NIK
Generic name: Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
Decision date: 2026-07-22
Decision code: OK30
Date received: 2026-06-26
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: implementing an automated vision inspection system and supporting manufacturing process controls for antenna alignment verification during connector module assembly