PMA P900052S014

Device: PORT-A-CATH EPIDURAL & PORT-A-CATH II LOW PROFILE EPIDURAL SYSTEMS
Applicant: Smiths Medical Asd, Inc.
PMA number: P900052
Supplement: S014
Product code: LNY
Decision date: 2007-08-28
Generic name: CATHETER, PERCUTANEOUS, LONG TERM, INTRASPINAL
Approval order statement: APPROVAL FOR A CHANGE TO THE IN-PROCESS MANUFACTURING PACKAGE INSPECTION PROCEDURE OF THE PORT-A-CATH EPIDURAL AND PORT-A-CATH II LOW PROFILE EPIDURAL SYSTEMS. THE MODIFICATIONS TO THE IN-PROCESS POUCH SEAL INSPECTION INCLUDES: 1) FIVE TEST INTERVALS WILL BE PERFORMED OVER A SINGLE DAY VERSUS THREE TEST INTERVALS PER EACH MANUFACTURING JOB. 2) THE CURRENT FIVE POUCHES TESTED USING THE PULL TEST WILL BE REDUCED TO TWO POUCHES PER TEST PERIOD AND THE CURRENT TWO POUCHES INSPECTED USING HAND PEEL AND VISUAL VERIFICATION WILL BE INCREASED TO FIVE POUCHES PER TEST PERIOD. 3) THE RESULTS OF THE GAGE PULL TEST AND VISUAL INSPECTION WILL BE RECORDED IN THE INDIVIDUAL JOB FOLDER PER ESTABLISHED TEST INTERVAL. 4) THE POUCH SEALING PROCESS PARAMETER SETTINGS WILL CONTINUE TO BE RECORDED FOR EACH JOB AND EACH INSPECTION INTERVAL.

Current openFDA PMA Record#

Device: PORT-A-CATH EPIDURAL & PORT-A-CATH II LOW PROFILE EPIDURAL SYSTEMS
Applicant: Smiths Medical Asd, Inc.
PMA number: P900052
Supplement: S014
Product code: LNY
Generic name: CATHETER, PERCUTANEOUS, LONG TERM, INTRASPINAL
Decision date: 2007-08-28
Decision code: APPR
Date received: 2006-12-08
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR A CHANGE TO THE IN-PROCESS MANUFACTURING PACKAGE INSPECTION PROCEDURE OF THE PORT-A-CATH EPIDURAL AND PORT-A-CATH II LOW PROFILE EPIDURAL SYSTEMS. THE MODIFICATIONS TO THE IN-PROCESS POUCH SEAL INSPECTION INCLUDES: 1) FIVE TEST INTERVALS WILL BE PERFORMED OVER A SINGLE DAY VERSUS THREE TEST INTERVALS PER EACH MANUFACTURING JOB. 2) THE CURRENT FIVE POUCHES TESTED USING THE PULL TEST WILL BE REDUCED TO TWO POUCHES PER TEST PERIOD AND THE CURRENT TWO POUCHES INSPECTED USING HAND PEEL AND VISUAL VERIFICATION WILL BE INCREASED TO FIVE POUCHES PER TEST PERIOD. 3) THE RESULTS OF THE GAGE PULL TEST AND VISUAL INSPECTION WILL BE RECORDED IN THE INDIVIDUAL JOB FOLDER PER ESTABLISHED TEST INTERVAL. 4) THE POUCH SEALING PROCESS PARAMETER SETTINGS WILL CONTINUE TO BE RECORDED FOR EACH JOB AND EACH INSPECTION INTERVAL.