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FDA PMA record

P130010

VEGA Steroid-Eluting Endocardial Leads (VEGA™ R45, VEGA™ R52, and VEGA™ R58)

Original premarket approval. Product code NVN. Decision 17 May 2023.

Approval

Each row is one field of the openFDA record. The grey name is the field’s name in openFDA’s documentation.

FieldValueField name
PMA numberP130010pma_number
Supplement numbernullsupplement_number
ApplicantMicroPort CRM USA, Inc.applicant
Trade nameVEGA Steroid-Eluting Endocardial Leads (VEGA™ R45, VEGA™ R52, and VEGA™ R58)trade_name
Generic nameDrug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodesgeneric_name
Product codeNVNproduct_code
Advisory committeeCardiovascularadvisory_committee_description
Date received2013-05-06date_received
Decision date2023-05-17decision_date
Decision codeAPPRdecision_code
Supplement typeemptysupplement_type
Supplement reasonemptysupplement_reason

Source: FDA openFDA, device/pma, P130010, retrieved 2026-09-24 16:04 Eastern. Public domain (CC0).

Product code

The FDA classification record for the code on this record.

NVN

Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

Device class 3 · Review panel CV

ArrHub vocabulary

Electrophysiology

NVN is one of the 56 product codes in ArrHub’s electrophysiology vocabulary, each held with its FDA classification record as its citation. Vocabulary entry verified 20 September 2026.

Supplement history

Every record of this PMA number in ArrHub’s verified view, newest first. Routine notices are listed, never summarised away.

RecordTypeReasonDecision
P130010 FDAoriginal approvalempty2023-05-17
P130010/S005 FDA30-Day NoticeProcess Change - Manufacturer/Sterilizer/Packager/Supplier2026-01-15

Source: FDA openFDA, device/pma, records of P130010, retrieved 2026-09-24 16:04 Eastern. 2 records in the verified view. Each identifier links to the FDA’s page.

ArrHub

What ArrHub adds to the record. Everything above this line is the agency’s; everything here is ArrHub’s, dated and attributed.

Record pair

No confirmed pair across the two registers for this record.

Resolution

No verified alias in ArrHub’s table; the name stands as the register spells it.

First seen by ArrHub’s weekly snapshot: 2026-09-27 03:05 Eastern.

Raw record

The stored record exactly as ArrHub holds it, for anyone who wants to check the page against it.

Show the raw record (JSON)device/pma.json?search=pma_number:P130010+AND+supplement_number:%22%22&limit=1
{
  "id": "6df0a389-f86d-4a87-9b4a-67984c3a0d3c",
  "pma_key": "P130010",
  "pma_number": "P130010",
  "supplement_number": null,
  "applicant": "MicroPort CRM USA, Inc.",
  "trade_name": "VEGA Steroid-Eluting Endocardial Leads (VEGA™ R45, VEGA™ R52, and VEGA™ R58)",
  "generic_name": "Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes",
  "product_code": "NVN",
  "advisory_committee_description": "Cardiovascular",
  "decision_date": "2023-05-17",
  "decision_code": "APPR",
  "supplement_type": "",
  "supplement_reason": "",
  "date_received": "2013-05-06",
  "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P130010",
  "verified_at": "2026-09-24T20:05:41.943+00:00",
  "created_at": "2026-09-24T20:05:32.87905+00:00",
  "collected_at": "2026-09-24T20:04:44.576+00:00",
  "last_checked_at": "2026-09-24T20:05:41.943+00:00"
}

The readable page is rendered from the record held in ArrHub’s verified view; the agency record at api.fda.gov governs where they differ.

Links open the agency’s own records. Unlabelled links open web pages. Links marked (JSON) open an agency’s data record, which a browser shows as plain text.

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