| Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
| |
| Device | VERCISE DEEP BRAIN STIMULATION (DBS)SYSTEM |
|---|
| Generic Name | Stimulator, electrical, implanted, for parkinsonian symptoms |
|---|
| Applicant | Boston Scientific Corp
25155 Rye Canyon Loop
Valencia, CA 91355 |
|---|
| PMA Number | P150031 |
|---|
| Supplement Number | S085 |
|---|
| Date Received | 05/02/2025 |
|---|
| Decision Date | 05/29/2025 |
|---|
| Product Code |
NHL |
| Advisory Committee |
Neurology |
|---|
| Supplement Type | Special (Immediate Track) |
|---|
| Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
|---|
| Expedited Review Granted? | No |
|---|
| Combination Product | No |
|---|
| Predetermined Change Control Plan Authorized | No |
|---|
Approval Order Statement
Approval for 1. Change to Item 6, Figure 21 to an image with a floating clip2. Added to Item 7, New Figure 22 with an extended lead (Figure 22. Push the Retaining Clip Into the Base)3. Added to Item 8: a. “Note: If you have difficulty locking the Slider, you may need to remove the Lead Stylet before locking the Slider in place, or replace the Retaining Clip using another Burr Hole Cover Kit or Burr Hole Cover Spares Kit.”b. Added New Figure 23 to include Lead and Screws (Figure 23. Lock the Slider) and remaining Figures shifted accordingly in sequence (previous Figure 23 is now Figure 24 etc.)4. Added to Item 9 Remove the Lead Stylet: “You may confirm the Slider is fully locked by repeating Step 8.”5. Changed Item 10 to “Verify that the DBS Lead has not moved from the desired location (e.g. by intraoperative imaging).” Previous Item 10 is now Item 11, and remaining steps shifted accordingly in sequence (previous Item 11 is now Item 12 etc) . |
|
|
