remede System
FDA premarket approval P160039/S011 · decided 2025-05-07
Approval details
- PMA number
- P160039
- Supplement
- S011
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- remede System
- Generic name
- Implanted phrenic nerve stimulator for central sleep apnea
- Applicant
- Respicardia
- Date received
- 2025-02-06
- Decision date
- 2025-05-07
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- PSR
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Minnetonka, MN
- Statement
- revised MR Conditional labeling of the remed?® System to remove the requirement to program the IPG to OFF mode prior to MRI scanning as the device automatically enters and remains in the Therapy Disabled (Magnet Mode) state during MRI exposure
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| RESPIGUIDE DELIVERY SYSTEM (K130378) | Respicardia | 2013-10-17 |