PORT-A-CATH(R) EPIDURAL IMPLANTABLE ACCESS SYST
FDA premarket approval P900052/S004 · decided 1997-05-23
Approval details
- PMA number
- P900052
- Supplement
- S004
- Supplement type
- Normal 180 Day Track
- Trade name
- PORT-A-CATH(R) EPIDURAL IMPLANTABLE ACCESS SYST
- Generic name
- CATHETER, PERCUTANEOUS, LONG TERM, INTRASPINAL
- Applicant
- Smiths Medical Asd, Inc.
- Date received
- 1996-02-23
- Decision date
- 1997-05-23
- Days to decision
- 455 days
- Decision code
- APPR
- Product code
- LNY
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- St. Paul, MN
- 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.
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