Pump, Infusion, Implanted, Programmable
Basic Information
- Device Name
- Pump, Infusion, Implanted, Programmable
- Trade Name
- MEDTRONIC SYNCHROMED INFUSION
- PMA Number
- P860004
- Supplement Number
- S081
- Device Class
- FDA Class 3
- Product Code
- LKK
- Generic Name
- Pump, infusion, implanted, programmable
- Medical Specialty
- Unknown
- Advisory Committee
- General Hospital
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- March 22, 2006
- Date Received
- January 13, 2006
- Supplement Type
- Real-Time Process
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR THE FOLLOWING CHANGES: 1) ADDING A SUTURELESS PUMP CONNECTOR TO BOTH MODELS 8709 AND 8731 CATHETERS COMPATIBLE WITH THE SYNCHROMED AND ISOMED IMPLANTABLE INFUSION PUMPS; 2) ADDING NUMBERS (IN CENTIMETERS) TO THE MARKINGS ON THE 8709 CATHETER BODY LIKE THOSE ON THE 8731 CATHETER; 3) ADDING A SHORTER (9.3 CM) INTRODUCER NEEDLE TO THE MODEL 8731 KIT; 4) ADDING CONNECTOR PINS AND STRAIN RELIEF SLEEVES TO MODEL 8731 CATHETER KIT ALLOWING THE PUMP SEGMENT OF THE CATHETER TO BE TRIMMED; 5) CREATE MODEL 8578 AS A REVISION KIT FOR 8709 OR 8709SC (SUTURELESS CONNECTOR) CONTAINING THE SUTURELESS CONNECTOR SEGMENT AND STRAIN RELIEF SLEEVES; 6) ADDING MODEL 8598A FOR CURRENT 8598 KIT (8731 SPINAL CATHETER SEGMENT REVISION KIT) MODIFIED TO CONTAIN THE SHORTER (9.3 CM) INTRODUCER NEEDLE; AND 7) MODEL 8596SC AS THE PUMP CONNECTOR IN THE CURRENT 8596 KIT (8731 PUMP CATHETER SEGMENT REVISION KIT) WAS REPLACED WITH THE SUTURELESS PUMP CONNECTOR.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LKK | Pump, Infusion, Implanted, Programmable | FDA class 3 | Unknown |