# P980049: Defender II Model 9201 Implantable Cardioverter Defibrillator

- Pathway: PMA
- Applicant: MicroPort CRM USA, Inc.
- Decided: Sep 15, 1999 after 271 days
- Product code: MRM (Defibrillator, Implantable, Dual-Chamber)
- Device class: 3
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Recalls of this device
- Jul 24, 2017 · Class II · Z-3232-2017: There is a possibility of overconsumption of certain PLATINIUM Implantable Cardiac Defibrillators (ICDs) and Cardiac ResynchronizationTherapy Defibrillators (CRT-Ds) following an ElectroStatic Dischar
- Jul 24, 2017 · Class II · Z-3231-2017: There is a possibility of overconsumption of certain PLATINIUM Implantable Cardiac Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) following an ElectroStatic Discha
- Jul 24, 2017 · Class II · Z-3229-2017: There is a possibility of overconsumption of certain PLATINIUM Implantable Cardiac Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) following an ElectroStatic Discha
- Jul 24, 2017 · Class II · Z-3228-2017: There is a possibility of overconsumption of certain PLATINIUM Implantable Cardiac Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) following an ElectroStatic Discha

Source page: https://510kreport.com/device/P980049
Methodology: https://510kreport.com/methodology