SYNCHROMED 2 MODEL 8637 PROGRAMMABLE DRUG INFUSION SYSTEM
FDA premarket approval P860004/S130 · decided 2011-07-01
Approval details
- PMA number
- P860004
- Supplement
- S130
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SYNCHROMED 2 MODEL 8637 PROGRAMMABLE DRUG INFUSION SYSTEM
- Generic name
- Pump, infusion, implanted, programmable
- Applicant
- Medtronic, Inc.
- Date received
- 2010-05-26
- Decision date
- 2011-07-01
- Days to decision
- 401 days
- Decision code
- APPR
- Product code
- LKK
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR DESIGN CHANGES TO THE BATTERY FOR THE SYNCHROMED II MODEL 8637 PROGRAMMABLE DRUG INFUSION SYSTEM.
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