- Device
- Implantable Cardioverter Defibrillator (ICD)
- Applicant
- MicroPort CRM USA, Inc.
- PMA number
- P980049
- Supplement
- S135
- Product code
- MRM
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Decision date
- 2020-06-24
- Decision code
- APPR
- Date received
- 2019-12-23
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for alternate hardware components and electronic configurations used on the electronic assembly, the V2.4.6 software update, and labeling updates.