INTRATHECAL CATHETER MODELS 8709, 8711, 8709SC, 8731SC, AND REVISION KIT 8598A
FDA premarket approval P860004/S088 · decided 2007-05-01
Approval details
- PMA number
- P860004
- Supplement
- S088
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- INTRATHECAL CATHETER MODELS 8709, 8711, 8709SC, 8731SC, AND REVISION KIT 8598A
- Generic name
- Pump, infusion, implanted, programmable
- Applicant
- Medtronic, Inc.
- Date received
- 2006-11-08
- Decision date
- 2007-05-01
- Days to decision
- 174 days
- Decision code
- APPR
- Product code
- LKK
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR: 1) A NEW CATHETER TIP PUSH-OUT FORCE SPECIFICATION; 2) A MODIFIED MANUFACTURING MONITORING PROCESS TO ASSURE CONFORMANCE TO NEW CATHETER TIP PUSH-OUT FORCE SPECIFICATION; 3) A CHANGE TO THE CATHETER TIP MATERIAL FOR CATHETER MODEL 8731SC AND REVISION KIT MODEL 8598A; AND 4) LABELING REVISIONS.
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510(k) clearances by this applicant
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