LOCATOR PLUS FAMILY OF DEFLECTABLE STYLETS

FDA premarket approval P960013/S022 · decided 2006-10-10

Approval details

PMA number

P960013

Supplement

S022

Supplement type

Real-Time Process

Supplement reason

Change Design/Components/Specifications/Material

Trade name

LOCATOR PLUS FAMILY OF DEFLECTABLE STYLETS

Generic name

Pulse generator, permanent, implantable

Applicant

ABBOTT MEDICAL

Date received

2006-08-17

Decision date

2006-10-10

Days to decision

54 days

Decision code

APPR

Product code

NVZ

Advisory committee

Cardiovascular

Expedited review

No

Location

Sylmar, CA

Statement

APPROVAL FOR THE LOCATOR PLUS FAMILY OF DEFLECTABLE STYLETS, MODELS 1281, 1282, 1283, 1291, 1292 AND 1293. THE LOCATOR PLUS STYLETS ARE SIMILAR TO THE APPROVED LOCATOR MODEL 4036 STEERABLE STYLET (PMA P960013/S010), BUT WITH SIX DIFFERENT COMBINATIONS OF TIP RADII AND STRAIGHT TIP LENGTHS. THE LOCATOR PLUS FAMILY OF DEFLECTABLE STYLETS ARE INTENDED FOR USE WHEN IMPLANTING COMPATIBLE ST. JUDE MEDICAL ACTIVE FIXATION STRAIGHT ENDOCARDIAL PACEMAKER LEADS, TENDRIL MODEL 1688 SDX AND HIGHER.

510(k) clearances by this applicant