PORT-A-CATH(R) EPIDURAL IMPLANTABLE ACCESS SYST
FDA premarket approval P900052/S005 · decided 1998-10-20
Approval details
- PMA number
- P900052
- Supplement
- S005
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- PORT-A-CATH(R) EPIDURAL IMPLANTABLE ACCESS SYST
- Generic name
- CATHETER, PERCUTANEOUS, LONG TERM, INTRASPINAL
- Applicant
- Smiths Medical Asd, Inc.
- Date received
- 1998-04-07
- Decision date
- 1998-10-20
- Days to decision
- 196 days
- Decision code
- APPR
- Product code
- LNY
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- St. Paul, MN
- Statement
- Approval for 1) The following design modifications to the current, legally marketed PORT-A-CATH(R) II: a smaller (25.4mm. based diameter, a 12.7mm. height, and a 8.9mm. septum diameter), lighter weight (5.0 grams) portal with a titanium outlet tube; a filter change from a 60 micron stainless steel(SS) screen to a 20 micron sintered titanium filter; and a change to a titanium locking wing portion of the CATH-SHIELD catheter connector; and 2) the labeling revisions as delineated in the first amend
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