PMA P900052

Device: PORT-A-CATH II LOW PROFILE EPIDURAL IMPLANTABLE ACCESS SYSTEM
Applicant: Smiths Medical Asd, Inc.
PMA number: P900052
Supplement: S018
Product code: LNY
Decision date: 2013-05-13
Generic name: CATHETER, PERCUTANEOUS, LONG TERM, INTRASPINAL
Approval order statement: CHANGE IN THE SYNTHESIS OF POLYTETRAFLUORO-ETHYLENE (PTFE), A SUBSTANCE USED IN THE MANUFACTURING OF THE COATING SYSTEM FOR THE GUIDEWIRE CONTAINED IN THE PORT-A-CATH II LOW PROFILE EPIDURAL IMPLANTABLE ACCESS SYSTEM. THIS CHANGE IN THE SYNTHESIS OF PTFE IS REQUIRED TO CONFORM TO U.S. ENVIRONMENTAL AGENCY 2010/2015 PFOA STEWARDSHIP PROGRAM RELATED TO THE USE OF PERFLUOROOCTANOIC ACID (PFOA).

Current openFDA PMA Record#

Device: PORT-A-CATH II LOW PROFILE EPIDURAL IMPLANTABLE ACCESS SYSTEM
Applicant: Smiths Medical Asd, Inc.
PMA number: P900052
Supplement: S018
Product code: LNY
Generic name: CATHETER, PERCUTANEOUS, LONG TERM, INTRASPINAL
Decision date: 2013-05-13
Decision code: OK30
Date received: 2013-04-22
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CHANGE IN THE SYNTHESIS OF POLYTETRAFLUORO-ETHYLENE (PTFE), A SUBSTANCE USED IN THE MANUFACTURING OF THE COATING SYSTEM FOR THE GUIDEWIRE CONTAINED IN THE PORT-A-CATH II LOW PROFILE EPIDURAL IMPLANTABLE ACCESS SYSTEM. THIS CHANGE IN THE SYNTHESIS OF PTFE IS REQUIRED TO CONFORM TO U.S. ENVIRONMENTAL AGENCY 2010/2015 PFOA STEWARDSHIP PROGRAM RELATED TO THE USE OF PERFLUOROOCTANOIC ACID (PFOA).