PORT-A-CATH EPIDURAL IMPLANTABLE ACCESS SYSTEM
FDA premarket approval P900052/S013 · decided 2007-04-05
Approval details
- PMA number
- P900052
- Supplement
- S013
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- PORT-A-CATH EPIDURAL IMPLANTABLE ACCESS SYSTEM
- Generic name
- CATHETER, PERCUTANEOUS, LONG TERM, INTRASPINAL
- Applicant
- Smiths Medical Asd, Inc.
- Date received
- 2006-07-26
- Decision date
- 2007-04-05
- Days to decision
- 253 days
- Decision code
- APPR
- Product code
- LNY
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- St. Paul, MN
- Statement
- APPROVAL FOR A SECOND OPERATOR INSPECTION FOR OUTLET TUBE AND INSERT HOLE ALIGNMENT TO CONFIRM PROPER ALIGNMENT OF THE OUTLET TUBE.
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