MEDTRONIC INTRATHECAL CATHETER MODEL 8731, MEDTRONIC INFUSION PUMP SYSTEM
FDA premarket approval P860004/S054 · decided 2002-10-11
Approval details
- PMA number
- P860004
- Supplement
- S054
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MEDTRONIC INTRATHECAL CATHETER MODEL 8731, MEDTRONIC INFUSION PUMP SYSTEM
- Generic name
- Pump, infusion, implanted, programmable
- Applicant
- Medtronic, Inc.
- Date received
- 2002-09-16
- Decision date
- 2002-10-11
- Days to decision
- 25 days
- Decision code
- APPR
- Product code
- LKK
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR THE FOLLOWING CHANGES TO INTRATHECAL CATHETER MODEL 8731: 1) PRE-ATTACHED TWO-PIECE CONNECTOR/ANCHOR 2) CATHETER TUBING MATERIAL WITH IMPROVED PHYSICAL PROPERTIES, 3) CATHETER TIP WITH IMPROVED RADIOPACITY, 4) LONGER INTRODUCER NEEDLE WITH DEPTH MARKINGS, 5) REVISION KITS (MODELS 8596 AND 8598), AND 6) CATHETER PASSER KITS (MODEL 8583 & 8686). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MEDTRONIC MODEL 8731 CLOSED-TIP INTRATHECAL CATHETER AND IS INDICATED FOR USE
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