PMA P060027S104

Device: Platinium CRT-D and Platinium 4LV CRT-D (Cardiac Resynchronization Therapy Defibrillator)
Applicant: MicroPort CRM USA, Inc.
PMA number: P060027
Supplement: S104
Product code: NIK
Decision date: 2020-10-20
Generic name: Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
Approval order statement: Alternate equipment to be used for microelectronic and Surface Mount Technology assembly.

Current openFDA PMA Record#

Device: Platinium CRT-D and Platinium 4LV CRT-D (Cardiac Resynchronization Therapy Defibrillator)
Applicant: MicroPort CRM USA, Inc.
PMA number: P060027
Supplement: S104
Product code: NIK
Generic name: Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
Decision date: 2020-10-20
Decision code: OK30
Date received: 2020-09-24
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Alternate equipment to be used for microelectronic and Surface Mount Technology assembly.