MEDTRONIC MODEL 8472 ISOMED CONSTANT-FLOW PUMP (ISOMED PUMP)
FDA premarket approval P860004/S109 · decided 2009-08-06
Approval details
- PMA number
- P860004
- Supplement
- S109
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- MEDTRONIC MODEL 8472 ISOMED CONSTANT-FLOW PUMP (ISOMED PUMP)
- Generic name
- Pump, infusion, implanted, programmable
- Applicant
- Medtronic, Inc.
- Date received
- 2009-07-09
- Decision date
- 2009-08-06
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- LKK
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR AN ERRATA INSERT COMMUNICATING THE INCOMPATIBILITY ISSUE OF THE SUTURELESS CONNECTORS TO THE MODEL 8472 ISOMED CONSTANT-FLOW PUMP.
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