PMA P900052S013

Device: PORT-A-CATH EPIDURAL IMPLANTABLE ACCESS SYSTEM
Applicant: Smiths Medical Asd, Inc.
PMA number: P900052
Supplement: S013
Product code: LNY
Decision date: 2007-04-05
Generic name: CATHETER, PERCUTANEOUS, LONG TERM, INTRASPINAL
Approval order statement: APPROVAL FOR A SECOND OPERATOR INSPECTION FOR OUTLET TUBE AND INSERT HOLE ALIGNMENT TO CONFIRM PROPER ALIGNMENT OF THE OUTLET TUBE.

Current openFDA PMA Record#

Device: PORT-A-CATH EPIDURAL IMPLANTABLE ACCESS SYSTEM
Applicant: Smiths Medical Asd, Inc.
PMA number: P900052
Supplement: S013
Product code: LNY
Generic name: CATHETER, PERCUTANEOUS, LONG TERM, INTRASPINAL
Decision date: 2007-04-05
Decision code: APPR
Date received: 2006-07-26
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR A SECOND OPERATOR INSPECTION FOR OUTLET TUBE AND INSERT HOLE ALIGNMENT TO CONFIRM PROPER ALIGNMENT OF THE OUTLET TUBE.