PMA P900052S006

Device: PORT-A-CATH(R) EPIDURAL IMPLANTABLE ACCESS SYST
Applicant: Smiths Medical Asd, Inc.
PMA number: P900052
Supplement: S006
Product code: LNY
Decision date: 1998-09-15
Generic name: CATHETER, PERCUTANEOUS, LONG TERM, INTRASPINAL
Approval order statement: Approval for a change in the postapproval protocol to allow the use of anesthetics or analgesics approved for epidural delivery when toxicity symptoms related to the use of preservative-free morphine develop or if there is inadequate pain relief.

Current openFDA PMA Record#

Device: PORT-A-CATH(R) EPIDURAL IMPLANTABLE ACCESS SYST
Applicant: Smiths Medical Asd, Inc.
PMA number: P900052
Supplement: S006
Product code: LNY
Generic name: CATHETER, PERCUTANEOUS, LONG TERM, INTRASPINAL
Decision date: 1998-09-15
Decision code: APPR
Date received: 1998-06-04
Supplement type: Normal 180 Day Track
Supplement reason: Postapproval Study Protocol
Approval order statement: Approval for a change in the postapproval protocol to allow the use of anesthetics or analgesics approved for epidural delivery when toxicity symptoms related to the use of preservative-free morphine develop or if there is inadequate pain relief.