PMA P900052S008

Device: PORTACATH/II EPIDURAL LOW PROFILE IMPLANTABLE ACCESS SYSTEM
Applicant: Smiths Medical Asd, Inc.
PMA number: P900052
Supplement: S008
Product code: LNY
Decision date: 1999-09-23
Generic name: CATHETER, PERCUTANEOUS, LONG TERM, INTRASPINAL
Approval order statement: The 30-day Notice requested a manufacturing process change for the Port-A-Cath(R) Epidural Implantable Access System and for the Port-A-Cath(R)II Epidural Low Profile(TM) Implantable Access System. This change would allow the use of an automated turbidometric assay method for determination of pyrogens using the LAL-5000 System with PYROS Software.

Current openFDA PMA Record#

Device: PORTACATH/II EPIDURAL LOW PROFILE IMPLANTABLE ACCESS SYSTEM
Applicant: Smiths Medical Asd, Inc.
PMA number: P900052
Supplement: S008
Product code: LNY
Generic name: CATHETER, PERCUTANEOUS, LONG TERM, INTRASPINAL
Decision date: 1999-09-23
Decision code: OK30
Date received: 1999-09-07
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: The 30-day Notice requested a manufacturing process change for the Port-A-Cath(R) Epidural Implantable Access System and for the Port-A-Cath(R)II Epidural Low Profile(TM) Implantable Access System. This change would allow the use of an automated turbidometric assay method for determination of pyrogens using the LAL-5000 System with PYROS Software.