PMA P050046S012

Device: ACUITY STEERABLE IS-1 LEADS
Applicant: Guidant Corp.
PMA number: P050046
Supplement: S012
Product code: NVY
Decision date: 2012-03-05
Classification: Permanent Defibrillator Electrodes
Generic name: Permanent defibrillator electrodes
Approval order statement: APPROVAL FOR THE FOLLOWING CHANGES: 1) ADDITION OF OPTINOVA AS SUPPLIER OF EXTRUDED POLYURETHANE TUBING; 2) MODIFICATION TO DIMENSIONAL TOLERANCES FOR EXTRUDED POLYURETHANE TUBING; 3) MODIFICATION TO POLYURETHANE TUBING SPECIFICATION FOR FOREIGN MATERIAL, BUBBLES, AND GEL INCLUSIONS; AND 4) REMOVAL OF REDUNDANT METHYLENE DIANILINE (MDA) RESIDUAL LEVEL REQUIREMENTS FOR EXTRUDED TUBING.

Current openFDA PMA Record#

Device: ACUITY STEERABLE IS-1 LEADS
Applicant: Guidant Corp.
PMA number: P050046
Supplement: S012
Product code: NVY
Generic name: Permanent defibrillator electrodes
Decision date: 2012-03-05
Decision code: APPR
Date received: 2011-12-02
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE FOLLOWING CHANGES: 1) ADDITION OF OPTINOVA AS SUPPLIER OF EXTRUDED POLYURETHANE TUBING; 2) MODIFICATION TO DIMENSIONAL TOLERANCES FOR EXTRUDED POLYURETHANE TUBING; 3) MODIFICATION TO POLYURETHANE TUBING SPECIFICATION FOR FOREIGN MATERIAL, BUBBLES, AND GEL INCLUSIONS; AND 4) REMOVAL OF REDUNDANT METHYLENE DIANILINE (MDA) RESIDUAL LEVEL REQUIREMENTS FOR EXTRUDED TUBING.