# P070008: Stratos LV CRT-P and Stratos LV-T CRT-P, Corox Otw BP Lead and Corox Otw-S BP Lead

- Pathway: PMA
- Applicant: Biotronik, Inc.
- Decided: May 12, 2008 after 427 days
- Product code: NKE (Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P))
- Device class: 3
- Recalls of this device: none
- 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.

Source page: https://510kreport.com/device/P070008
Methodology: https://510kreport.com/methodology