remede System
FDA premarket approval P160039/S006 · decided 2021-07-28
Approval details
- PMA number
- P160039
- Supplement
- S006
- 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
- 2021-01-19
- Decision date
- 2021-07-28
- Days to decision
- 190 days
- Decision code
- APPR
- Product code
- PSR
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Minnetonka, MN
- Statement
- Approval for reducing the IPG size, increasing the IPG battery longevity, reducing the number of set screw connections between the lead terminal and IPG header, and improving features within the Remede Programer software application and the remede Reports application.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| RESPIGUIDE DELIVERY SYSTEM (K130378) | Respicardia | 2013-10-17 |