PMA P960013S022

Device: LOCATOR PLUS FAMILY OF DEFLECTABLE STYLETS
Applicant: ABBOTT MEDICAL
PMA number: P960013
Supplement: S022
Product code: NVZ
Decision date: 2006-10-10
Generic name: Pulse generator, permanent, implantable
Approval order 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.

Current openFDA PMA Record#

Device: LOCATOR PLUS FAMILY OF DEFLECTABLE STYLETS
Applicant: ABBOTT MEDICAL
PMA number: P960013
Supplement: S022
Product code: NVZ
Generic name: Pulse generator, permanent, implantable
Decision date: 2006-10-10
Decision code: APPR
Date received: 2006-08-17
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order 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.