PORTACATH/II EPIDURAL LOW PROFILE IMPLANTABLE ACCESS SYSTEM
FDA premarket approval P900052/S008 · decided 1999-09-23
Approval details
- PMA number
- P900052
- Supplement
- S008
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- PORTACATH/II EPIDURAL LOW PROFILE IMPLANTABLE ACCESS SYSTEM
- Generic name
- CATHETER, PERCUTANEOUS, LONG TERM, INTRASPINAL
- Applicant
- Smiths Medical Asd, Inc.
- Date received
- 1999-09-07
- Decision date
- 1999-09-23
- Days to decision
- 16 days
- Decision code
- OK30
- Product code
- LNY
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- St. Paul, MN
- Statement
- The 30-day Notice requested a manufacturing process change for the Port-A-Cath(R) Epidural Implantable Access System and for the Port-A-Cath(R)II Epidural Low Profile(TM) Implantable Access System. This change would allow the use of an automated turbidometric assay method for determination of pyrogens using the LAL-5000 System with PYROS Software.
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