PMA P900052S016

Device
PORT-A-CATH EPIDURAL IMPLANTABLE ACCESS SYSTEM AND PORT-A-CATH II LOW PROFILE EPIDURAL IMPLANTABLE ACCESS SYSTEM
Applicant
Smiths Medical Asd, Inc.
PMA number
P900052
Supplement
S016
Product code
LNY
Decision date
2009-04-20
Generic name
CATHETER, PERCUTANEOUS, LONG TERM, INTRASPINAL
Approval order statement
APPROVAL FOR A LABEL CLAIM ¿DOES NOT CONTAIN NATURAL RUBBER LATEX.¿

Current openFDA PMA Record#

Device
PORT-A-CATH EPIDURAL IMPLANTABLE ACCESS SYSTEM AND PORT-A-CATH II LOW PROFILE EPIDURAL IMPLANTABLE ACCESS SYSTEM
Applicant
Smiths Medical Asd, Inc.
PMA number
P900052
Supplement
S016
Product code
LNY
Generic name
CATHETER, PERCUTANEOUS, LONG TERM, INTRASPINAL
Decision date
2009-04-20
Decision code
APPR
Date received
2008-08-11
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
APPROVAL FOR A LABEL CLAIM ¿DOES NOT CONTAIN NATURAL RUBBER LATEX.¿