Implantica CE Reflux , Ltd.: PMA approval for RefluxStop® Device and RefluxStop® Deployment Tool

Implantica CE Reflux , Ltd. (San Gwann): PMA approval for RefluxStop® Device and RefluxStop® Deployment Tool. Dated 76 days ago, it serves as a historical benchmark. Score 55/100. 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: 499 related FdaApprovalPulse records and the 4-column CSV export.

FieldValue
SponsorImplantica CE Reflux , Ltd.
ProductRefluxStop® Device and RefluxStop® Deployment Tool
Generic / ingredientIMPLANT, ANTI-GASTROESOPHAGEAL REFLUX
ApprovalPMA original approval (new class III device)
ApplicationP250018
Decided2026-08-20
Panel / classGastroenterology, Urology
Sponsor locationSan Gwann
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  • Source agency: openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration)
  • Record date: 2026-08-20
  • Data refreshed: 2026-11-04
  • Refunds on request within 14 days

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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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55 / 100 Score

  • A new product launch.

What is the FdaApprovalPulse record for Implantica CE Reflux , Ltd. in San Gwann?

The FDA approved RefluxStop® Device and RefluxStop® Deployment Tool (P250018) for Implantica CE Reflux , Ltd. on 2026-08-20: PMA original approval (new class iii device).

How does Implantica CE Reflux , Ltd. compare to other FdaApprovalPulse records?

It is 76 days old; check the official source for later updates before acting.

Implantica CE Reflux , Ltd. vs. top 3 peers

OrganizationLocationRecord date
Implantica CE Reflux , Ltd.San Gwann2026-08-20
Vivasure Medical , Ltd.Galway2026-10-16
Edwards Lifesciences, LLCIrvine, CA2026-10-01
Rejoni, Inc.Bedford, MA2026-09-28

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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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