PORT-A-CATH EPIDURAL/PORT-A-CATH II LOW PROFILE EPIDURAL SYSTEMS
FDA premarket approval P900052/S011 · decided 2002-10-03
Approval details
- PMA number
- P900052
- Supplement
- S011
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- PORT-A-CATH EPIDURAL/PORT-A-CATH II LOW PROFILE EPIDURAL SYSTEMS
- Generic name
- CATHETER, PERCUTANEOUS, LONG TERM, INTRASPINAL
- Applicant
- Smiths Medical Asd, Inc.
- Date received
- 2002-09-04
- Decision date
- 2002-10-03
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- LNY
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- St. Paul, MN
- Statement
- CHANGE IN THE METHOD OF MARKING THE PRODUCT NAME AND LOT NUMBER ON THE PORTAL RESERVOIRS FROM ENGRAVING TO LASER MARKING.
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