PMA P150031S085

Device: VERCISE DEEP BRAIN STIMULATION (DBS)SYSTEM
Applicant: Boston Scientific Corp
PMA number: P150031
Supplement: S085
Product code: NHL
Decision date: 2025-05-29
Classification: Neurology
Generic name: Stimulator, electrical, implanted, for parkinsonian symptoms
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) .

Current openFDA PMA Record#

Device: VERCISE DEEP BRAIN STIMULATION (DBS)SYSTEM
Applicant: Boston Scientific Corp
PMA number: P150031
Supplement: S085
Product code: NHL
Generic name: Stimulator, electrical, implanted, for parkinsonian symptoms
Decision date: 2025-05-29
Decision code: APPR
Date received: 2025-05-02
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
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) .