PMA P980049S147

Device: Platinium VR 1210, Platinium VR 1240, ENERGYA VR 3110, TALENTIA VR 3210, ENERGYA VR 3140, TALENTIA VR 3240, Platinium DR
Applicant: MicroPort CRM USA, Inc.
PMA number: P980049
Supplement: S147
Product code: MRM
Decision date: 2025-07-23
Classification: Cardiovascular
Generic name: DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
Approval order statement: Approval for the addition of Mylar spacers to our ALIZEA/CELEA pacemakers, allow hybrid tab replacements to occur at Microport’s Saluggia, Italy facility, and changes in manufacturing processes of other MicroPort’s pacemaker, ICD, and CRT-D systems.

Current openFDA PMA Record#

Device: Platinium VR 1210, Platinium VR 1240, ENERGYA VR 3110, TALENTIA VR 3210, ENERGYA VR 3140, TALENTIA VR 3240, Platinium DR
Applicant: MicroPort CRM USA, Inc.
PMA number: P980049
Supplement: S147
Product code: MRM
Generic name: DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
Decision date: 2025-07-23
Decision code: APPR
Date received: 2025-04-18
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for the addition of Mylar spacers to our ALIZEA/CELEA pacemakers, allow hybrid tab replacements to occur at Microport’s Saluggia, Italy facility, and changes in manufacturing processes of other MicroPort’s pacemaker, ICD, and CRT-D systems.