# P000009: Phylax AV Icd System

- Pathway: PMA
- Applicant: Biotronik, Inc.
- Decided: Sep 29, 2000 after 228 days
- Product code: MRM (Defibrillator, Implantable, Dual-Chamber)
- Device class: 3
- Recalls of this device: 1 (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
- Feb 21, 2003 · Not classified · Z-0700-03: Potential for battery to delivery less than full amount of energy.

Source page: https://510kreport.com/device/P000009
Methodology: https://510kreport.com/methodology