Implantable System for Remodulin
FDA premarket approval P140032/S002 · decided 2018-04-17
Approval details
- PMA number
- P140032
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Implantable System for Remodulin
- Generic name
- Pump, infusion, implanted, programmable
- Applicant
- Medtronic, Inc.
- Date received
- 2018-02-01
- Decision date
- 2018-04-17
- Days to decision
- 75 days
- Decision code
- APPR
- Product code
- LKK
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Approval for changes made to the design history file and device master record of the motor component of the SynchroMed II Implantable System for Remodulin, (Model 8637P), the associated parts of the motor (i.e. assemblies, subassemblies, components, subcomponents, and materials used in the manufacturing of the motor assembly), and the pumphead assembly material specifications.
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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 |
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