STRATOS LV-T

FDA premarket approval P070008/S009 · decided 2009-05-12

Approval details

PMA number

P070008

Supplement

S009

Supplement type

Normal 180 Day Track

Supplement reason

Labeling Change - Indications/instructions/shelf life/tradename

Trade name

STRATOS LV-T

Generic name

Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)

Applicant

Biotronik, Inc.

Date received

2009-01-26

Decision date

2009-05-12

Days to decision

106 days

Decision code

APPR

Product code

NKE

Advisory committee

Cardiovascular

Expedited review

No

Location

Lake Oswego, OR

Statement

APPROVAL FOR MODIFICATION OF PRODUCT LABELING FOR DEVICES THAT UTILIZE HOME MONITORING. SPECIFICALLY, SUPPLEMENTS REQUESTED APPROVAL FOR THE REPLACEMENT OF EXISTINGPRECAUTIONS AND THE FOLLOWING MARKETING STATEMENTS:1) BIOTRONIC HOME MONITORING INFORMATION MAY BE USED AS A REPLACEMENT FORDEVICE INTERROGATION DURING IN-OFFICE FOLLOW-UP VISITS.2) A STRATEGY OF CARE USING BIOTRONIK HOME MONITORING WITH OFFICE VISITS WHEN NEEDED - HAS BEEN SHOWN TO EXTEND THE LIME BETWEEN ROUTINE, SCHEDULED IN-OFFICE

510(k) clearances by this applicant