remede® System
FDA premarket approval P160039/S008 · decided 2023-03-28
Approval details
- PMA number
- P160039
- Supplement
- S008
- 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
- 2022-03-01
- Decision date
- 2023-03-28
- Days to decision
- 392 days
- Decision code
- APPR
- Product code
- PSR
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Minnetonka, MN
- Statement
- Approval for adding MR Conditional labeling for 1.5T and 3T MRI scans to the implantable components of remede System.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| RESPIGUIDE DELIVERY SYSTEM (K130378) | Respicardia | 2013-10-17 |