PMA supplement
P010032 S191: Prodigy, Proclaim XR, Proclaim Plus, and Externa Spinal Cord Stimulation (SCS) Systems
FDA PMA supplement · Panel Track · ABBOTT MEDICAL
Key facts
| Original PMA | P010032 |
|---|---|
| Supplement number | S191 |
| Supplement type | Panel Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | Prodigy, Proclaim XR, Proclaim Plus, and Externa Spinal Cord Stimulation (SCS) Systems |
| Generic name | Stimulator, spinal-cord, totally implanted for pain relief |
| Applicant | ABBOTT MEDICAL |
| Product code | LGW |
| Received date | Sep 2, 2022 |
| Decision date | May 10, 2023 |
At a glance
- No Expedited review granted
- Yes Approval order on file
- Yes Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: