SYNCHROMED II IMPLANTABLE INFUSION SYSTEM
FDA premarket approval P860004/S070 · decided 2005-09-26
Approval details
- PMA number
- P860004
- Supplement
- S070
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SYNCHROMED II IMPLANTABLE INFUSION SYSTEM
- Generic name
- Pump, infusion, implanted, programmable
- Applicant
- Medtronic, Inc.
- Date received
- 2005-03-31
- Decision date
- 2005-09-26
- Days to decision
- 179 days
- Decision code
- APPR
- Product code
- LKK
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR THE MODEL 8832 PERSONAL THERAPY MANAGER (PTM), AN ACCESSORY TO THE SYNCHROMED II IMPLANTABLE INFUSION SYSTEM, INDICATED FOR THE PATIENT TO ACTIVATE DELIVERY OF PHYSICIAN PROGRAMMED SUPPLEMENTAL DOSES OF PRESERVATIVE-FREE MORPHINE SULFATE STERILE SOLUTION FROM THE SYNCHROMED II PUMP FOR THE TREATMENT OF CHRONIC INTRACTABLE PAIN.
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510(k) clearances by this applicant
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|---|---|---|
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| Bio-Medicus Life Support Catheter and Introducer (K251831) | Medtronic, Inc. | 2026-01-15 |
| Concerto Versa™ Detachable Coil (K253511) | Medtronic, Inc. | 2026-01-14 |
| C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48), C320LBB Delivery System (C320LBBL45), C320LBB Delivery System (C320LBBL48) (K253409) | Medtronic, Inc. | 2025-12-19 |