MEDTRONIC ISOMED MODEL 8472 FIXED RATE INFUSION SYSTEM
FDA premarket approval P990034/S004 · decided 2003-07-21
Approval details
- PMA number
- P990034
- Supplement
- S004
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- MEDTRONIC ISOMED MODEL 8472 FIXED RATE INFUSION SYSTEM
- Generic name
- Pump, infusion, implanted, programmable
- Applicant
- Medtronic, Inc.
- Date received
- 2003-06-18
- Decision date
- 2003-07-21
- Days to decision
- 33 days
- Decision code
- APPR
- Product code
- LKK
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR LABELING CHANGES TO THE MODELS 8553 AND 8555 ISOMED REFILL KIT INSTRUCTIONS FOR USE AND THE TECHNICAL MANUAL.
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