Implantable System for Remodulin
FDA premarket approval P140032/S057 · decided 2020-09-22
Approval details
- PMA number
- P140032
- Supplement
- S057
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Implantable System for Remodulin
- Generic name
- Pump, infusion, implanted, programmable
- Applicant
- Medtronic, Inc.
- Date received
- 2020-06-01
- Decision date
- 2020-09-22
- Days to decision
- 113 days
- Decision code
- APPR
- Product code
- LKK
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Approval for change to improve the final product yield in the final pack manufacturing step to confirm telemetry of the SynchroMed II Implantable Infusion Pump Model 8637 for the Implantable System for Remodulin.
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510(k) clearances by this applicant
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|---|---|---|
| VitalFlow Set with Balance™ Biosurface (K261335) | Medtronic, Inc. | 2026-07-31 |
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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 |
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