PMA P900052S004
- Device
- PORT-A-CATH(R) EPIDURAL IMPLANTABLE ACCESS SYST
- Applicant
- Smiths Medical Asd, Inc.
- PMA number
- P900052
- Supplement
- S004
- Product code
- LNY
- Decision date
- 1997-05-23
- Generic name
- CATHETER, PERCUTANEOUS, LONG TERM, INTRASPINAL
- Approval order statement
- APPROVAL FOR A CHANGE IN INDICATIONS FOR USE TO INCLUDE LONG-TERM, REPEATED ACCESS TO THE EPIDURAL SPACE FOR THE DELIVERY OF PRESERVATIVE-FREE MORPHINE SULFATE TO RELIEVE CHRONIC INTRACTABLE PAIN OF NON-MALIGNANT ORIGIN.
Current openFDA PMA Record#
- Device
- PORT-A-CATH(R) EPIDURAL IMPLANTABLE ACCESS SYST
- Applicant
- Smiths Medical Asd, Inc.
- PMA number
- P900052
- Supplement
- S004
- Product code
- LNY
- Generic name
- CATHETER, PERCUTANEOUS, LONG TERM, INTRASPINAL
- Decision date
- 1997-05-23
- Decision code
- APPR
- Date received
- 1996-02-23
- Supplement type
- Normal 180 Day Track
- Approval order statement
- APPROVAL FOR A CHANGE IN INDICATIONS FOR USE TO INCLUDE LONG-TERM, REPEATED ACCESS TO THE EPIDURAL SPACE FOR THE DELIVERY OF PRESERVATIVE-FREE MORPHINE SULFATE TO RELIEVE CHRONIC INTRACTABLE PAIN OF NON-MALIGNANT ORIGIN.