remede® System
FDA premarket approval P160039/S007 · decided 2022-01-10
Approval details
- PMA number
- P160039
- Supplement
- S007
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- remede® System
- Generic name
- Implanted phrenic nerve stimulator for central sleep apnea
- Applicant
- Respicardia
- Date received
- 2021-08-06
- Decision date
- 2022-01-10
- Days to decision
- 157 days
- Decision code
- APPR
- Product code
- PSR
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Minnetonka, MN
- Statement
- Approval of a change to the GEN 1.5 IPG firmware (FW) from version 1.13 to version 1.14.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| RESPIGUIDE DELIVERY SYSTEM (K130378) | Respicardia | 2013-10-17 |