Boston Scientific Corp: PMA supplement approved for Vercise DBS Systems

Boston Scientific Corp (Valencia, California): PMA supplement approved for Vercise DBS Systems. Dated 20 days ago, it is in the active follow-up window. Score 60/100. As of 2026-11-04, from openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration).

Data as of · Compiled by Zalwin from openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration)

Free preview: all 8 published fields of this record are shown below. Locked: 109 related CA FdaApprovalPulse records and the 4-column CSV export.

FieldValue
SponsorBoston Scientific Corp
ProductVercise DBS Systems
Generic / ingredientStimulator, electrical, implanted, for parkinsonian symptoms
ApprovalPMA supplement (device change)
ApplicationP150031 S100
Decided2026-10-15
Panel / classNeurology
Sponsor locationValencia, CA
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  • Source agency: openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration)
  • Record date: 2026-10-15
  • Data refreshed: 2026-11-04
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LIVE PUBLIC DATA Source: openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration) · Last refreshed: Wed, 04 Nov 2026 06:06:18 GMT

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Peer benchmark and outreach value: Boston Scientific Corp and 110 California peers

  • California FdaApprovalPulse records like this one: 110
  • Timing: Medium: dated in the last 30 days
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60 / 100 Score

  • Decided in the last 30 days.

What is the FdaApprovalPulse record for Boston Scientific Corp in Valencia, California?

The FDA approved Vercise DBS Systems (P150031 S100) for Boston Scientific Corp on 2026-10-15: PMA supplement (device change).

How does Boston Scientific Corp compare to other California FdaApprovalPulse records?

It is 20 days old, still within a typical 45-day follow-up window.

Boston Scientific Corp vs. top 3 peers

OrganizationLocationRecord date
Boston Scientific CorpValencia, CA2026-10-15
Edwards Lifesciences, LLCIrvine, CA2026-10-22
Edwards Lifesciences, LLCIrvine, CA2026-10-22
Edwards Lifesciences, LLCIrvine, CA2026-10-22

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From openFDA (PMA and Drugs@FDA). openFDA can lag FDA decisions by days to weeks. Drug supplement types follow the FDA submission class (labeling and REMS, manufacturing/CMC, efficacy, other). Company and product level only. Verify on FDA databases before relying on an approval.

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