Defibtech, LLC: PMA supplement approved for Defibtech Lifeline; Defibtech Lifeline AUTO; Defibtech Lifeline VIEW; Defibtech Lifeline V

Defibtech, LLC (Guilford, Connecticut): PMA supplement approved for Defibtech Lifeline; Defibtech Lifeline AUTO; Defibtech Lifeline VIEW; Defibtech Lifeline V. Dated 141 days ago, it serves as a historical benchmark. Score 30/100. 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: 3 related CT FdaApprovalPulse records and the 4-column CSV export.

FieldValue
SponsorDefibtech, LLC
ProductDefibtech Lifeline; Defibtech Lifeline AUTO; Defibtech Lifeline VIEW; Defibtech Lifeline VIEW AUTO; Defibtech Lifeline E
Generic / ingredientAutomated external defibrillators (non-wearable)
ApprovalPMA supplement (device change)
ApplicationP160032 S015
Decided2026-06-16
Panel / classCardiovascular
Sponsor locationGuilford, CT
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  • Source agency: openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration)
  • Record date: 2026-06-16
  • 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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Peer benchmark and outreach value: Defibtech, LLC and 4 Connecticut peers

  • Connecticut FdaApprovalPulse records like this one: 4
  • Timing: Low: older than 30 days
  • Estimated pipeline if you contact every Connecticut peer: $800 (peers × rate × deal size; an estimate from your assumptions, not a forecast)

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30 / 100 Score

    What is the FdaApprovalPulse record for Defibtech, LLC in Guilford, Connecticut?

    The FDA approved Defibtech Lifeline; Defibtech Lifeline AUTO; Defibtech Lifeline VIEW; Defibtech Lifeline VIEW AUTO; Defibtech Lifeline E (P160032 S015) for Defibtech, LLC on 2026-06-16: PMA supplement (device change).

    How does Defibtech, LLC compare to other Connecticut FdaApprovalPulse records?

    It is 141 days old; check the official source for later updates before acting. Its Score of 30/100 is modest; treat it as background rather than a priority.

    Defibtech, LLC vs. top 3 peers

    OrganizationLocationRecord date
    Defibtech, LLCGuilford, CT2026-06-16
    Instylla, Inc.Bedford, MA2026-10-23
    Ventana Medical Systems, Inc. (Roche Tissue Diagnostics)Tucson, AZ2026-10-23
    Cerenovus, Inc.Miami, FL2026-10-23

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    ✓ Read-only, live public data · Key and unlock right after payment · Card, Apple Pay, Google Pay or Link via Stripe · Refunds on request within 14 days

    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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