MEDTRONIC INSYNC(TM) BIVENTRICAL PACING SYSTEM

Original premarket approval. Product code LWP. Decision 28 August 2001.

Approval

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

Field	Value	Field name
PMA number	P010015	pma_number
Supplement number	null	supplement_number
Applicant	Medtronic, Inc.	applicant
Trade name	MEDTRONIC INSYNC(TM) BIVENTRICAL PACING SYSTEM	trade_name
Generic name	Implantable pulse generator, pacemaker (non-CRT)	generic_name
Product code	LWP	product_code
Advisory committee	Cardiovascular	advisory_committee_description
Date received	2001-03-02	date_received
Decision date	2001-08-28	decision_date
Decision code	APPR	decision_code
Supplement type	empty	supplement_type
Supplement reason	empty	supplement_reason

Source: FDA openFDA, device/pma, P010015, retrieved 2026-09-24 16:04 Eastern. Public domain (CC0).

Product code

The FDA classification record for the code on this record.

LWP

Implantable Pulse Generator, Pacemaker (Non-Crt)

Device class 3 · Review panel CV

All records with this codeClassification record on FDA

ArrHub vocabulary

Electrophysiology

LWP 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.

Record	Type	Reason	Decision
P010015 FDA	original approval	empty	2001-08-28
P010015/S589 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2026-07-31
P010015/S588 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2026-07-31
P010015/S587 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2026-07-16
P010015/S583 FDA	Real-Time Process	Change Design/Components/Specifications/Material	2026-05-14
P010015/S581 FDA	Real-Time Process	Change Design/Components/Specifications/Material	2026-04-30
P010015/S585 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2026-04-23
P010015/S586 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2026-04-15
P010015/S584 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2026-03-27
P010015/S582 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2026-03-06
P010015/S580 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2026-02-12
P010015/S579 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2026-02-10
P010015/S578 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2026-02-10
P010015/S577 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2026-01-23
P010015/S576 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2026-01-23

Source: FDA openFDA, device/pma, records of P010015, retrieved 2026-09-24 16:04 Eastern. 15 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.

Resolved to

Medtronic

The register name above is resolved to its organisation under ArrHub’s alias table. Method: rule:normalize. Source: fda_applicant. Verified 20 September 2026.

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:P010015+AND+supplement_number:%22%22&limit=1

{
  "id": "00218e52-2bd8-421a-8d14-35250375c584",
  "pma_key": "P010015",
  "pma_number": "P010015",
  "supplement_number": null,
  "applicant": "Medtronic, Inc.",
  "trade_name": "MEDTRONIC INSYNC(TM) BIVENTRICAL PACING SYSTEM",
  "generic_name": "Implantable pulse generator, pacemaker (non-CRT)",
  "product_code": "LWP",
  "advisory_committee_description": "Cardiovascular",
  "decision_date": "2001-08-28",
  "decision_code": "APPR",
  "supplement_type": "",
  "supplement_reason": "",
  "date_received": "2001-03-02",
  "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P010015",
  "verified_at": "2026-09-24T20:05:26.987+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": "2026-09-24T20:05:26.987+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.

Report a broken link or a record that does not match its source: alerts@arrhub.com. Corrections are published, with their date, at arrhub.com/corrections.