LLESTO, IFORIA, LUMAX,

FDA premarket approval P050023/S067 · decided 2013-07-30

Approval details

PMA number

P050023

Supplement

S067

Supplement type

Real-Time Process

Supplement reason

Labeling Change - Indications/instructions/shelf life/tradename

Trade name

LLESTO, IFORIA, LUMAX,

Generic name

DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER

Applicant

Biotronik, Inc.

Date received

2013-06-14

Decision date

2013-07-30

Days to decision

46 days

Decision code

APPR

Product code

MRM

Advisory committee

Cardiovascular

Expedited review

No

Location

Lake Oswego, OR

Statement

APPROVAL FOR THE MINOR LABELING MODIFICATIONS/CORRECTIONS, WHICH INCLUDES AN UPDATE OF THE INDICATION FOR USE STATEMENTS (IFU) TO INCLUDE THE MARKET APPROVED DEVICES WITH THE SAME IFU, AND OTHER MINOR CORRECTIONS TO THE LABELING.

510(k) clearances by this applicant