PMA P900052S012

Device: PORT-A-CATH EPIDURAL IMPLANTABLE ACCESS SYSTEM, PORT-A-CATH EPIDURAL LOW PROFILE IMPLANTABLE ACCESS SYSTEM
Applicant: Smiths Medical Asd, Inc.
PMA number: P900052
Supplement: S012
Product code: LNY
Decision date: 2002-12-17
Generic name: CATHETER, PERCUTANEOUS, LONG TERM, INTRASPINAL
Approval order statement: APPROVAL FOR: 1) THE ADDITION OF PROCEDURAL ACCESSORIES TO THE PORT-A-CATH EPIDURAL SYSTEM KIT, 2) AN ALTERNATE PACKAGING CONFIGURATION AND 3) CHANGE IN ETHYLENE OXIDE RESIDUAL LIMITS. THESE ADDED ACCESSORIES ARE EXACTLY THE SAME AS THOSE DESCRIBED IN P900052/S005 FOR PORT-A-CATH II EPIDURAL LOW-PROFILE SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME PORT-A-CATH EPIDURAL LOW PROFILE IMPLANTABLE ACCESS SYSTEM AND PORT-A-CATH EPIDURAL SYSTEM KITS.

Current openFDA PMA Record#

Device: PORT-A-CATH EPIDURAL IMPLANTABLE ACCESS SYSTEM, PORT-A-CATH EPIDURAL LOW PROFILE IMPLANTABLE ACCESS SYSTEM
Applicant: Smiths Medical Asd, Inc.
PMA number: P900052
Supplement: S012
Product code: LNY
Generic name: CATHETER, PERCUTANEOUS, LONG TERM, INTRASPINAL
Decision date: 2002-12-17
Decision code: APPR
Date received: 2002-10-30
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR: 1) THE ADDITION OF PROCEDURAL ACCESSORIES TO THE PORT-A-CATH EPIDURAL SYSTEM KIT, 2) AN ALTERNATE PACKAGING CONFIGURATION AND 3) CHANGE IN ETHYLENE OXIDE RESIDUAL LIMITS. THESE ADDED ACCESSORIES ARE EXACTLY THE SAME AS THOSE DESCRIBED IN P900052/S005 FOR PORT-A-CATH II EPIDURAL LOW-PROFILE SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME PORT-A-CATH EPIDURAL LOW PROFILE IMPLANTABLE ACCESS SYSTEM AND PORT-A-CATH EPIDURAL SYSTEM KITS.