- Device
- PORT-A-CATH EPIDURAL/PORT-A-CATH II LOW PROFILE EPIDURAL SYSTEMS
- Applicant
- Smiths Medical Asd, Inc.
- PMA number
- P900052
- Supplement
- S011
- Product code
- LNY
- Generic name
- CATHETER, PERCUTANEOUS, LONG TERM, INTRASPINAL
- Decision date
- 2002-10-03
- Decision code
- OK30
- Date received
- 2002-09-04
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE IN THE METHOD OF MARKING THE PRODUCT NAME AND LOT NUMBER ON THE PORTAL RESERVOIRS FROM ENGRAVING TO LASER MARKING.