PORT-A-CATH EPIDURAL IMPLANTABLE ACCESS SYSTEM, PORT-A-CATH EPIDURAL LOW PROFILE IMPLANTABLE ACCESS SYSTEM
FDA premarket approval P900052/S012 · decided 2002-12-17
Approval details
- PMA number
- P900052
- Supplement
- S012
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- PORT-A-CATH EPIDURAL IMPLANTABLE ACCESS SYSTEM, PORT-A-CATH EPIDURAL LOW PROFILE IMPLANTABLE ACCESS SYSTEM
- Generic name
- CATHETER, PERCUTANEOUS, LONG TERM, INTRASPINAL
- Applicant
- Smiths Medical Asd, Inc.
- Date received
- 2002-10-30
- Decision date
- 2002-12-17
- Days to decision
- 48 days
- Decision code
- APPR
- Product code
- LNY
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- St. Paul, MN
- Statement
- APPROVAL FOR: 1) THE ADDITION OF PROCEDURAL ACCESSORIES TO THE PORT-A-CATH EPIDURAL SYSTEM KIT, 2) AN ALTERNATE PACKAGING CONFIGURATION AND 3) CHANGE IN ETHYLENE OXIDE RESIDUAL LIMITS. THESE ADDED ACCESSORIES ARE EXACTLY THE SAME AS THOSE DESCRIBED IN P900052/S005 FOR PORT-A-CATH II EPIDURAL LOW-PROFILE SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME PORT-A-CATH EPIDURAL LOW PROFILE IMPLANTABLE ACCESS SYSTEM AND PORT-A-CATH EPIDURAL SYSTEM KITS.
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