Implantable Pulse Generator, Pacemaker (Non-Crt)
Device class 3 · Review panel CV
FDA PMA supplement record
P010015/S583
Percepta Bipolar CRT-P (WlTR0l); Percepta Quadripolar CRT-P (W4TR01); Serena Bipolar CRT-P (WlTR02); Serena Quadripolar (truncated in the FDA record)
Supplement S583 to premarket approval P010015. Product code LWP. Decision 14 May 2026.
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 | S583 | supplement_number |
| Applicant | Medtronic, Inc. | applicant |
| Trade name | Percepta Bipolar CRT-P (WlTR0l); Percepta Quadripolar CRT-P (W4TR01); Serena Bipolar CRT-P (WlTR02); Serena Quadripolar (truncated in the FDA record) | 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 | 2026-02-13 | date_received |
| Decision date | 2026-05-14 | decision_date |
| Decision code | APPR | decision_code |
| Supplement type | Real-Time Process | supplement_type |
| Supplement reason | Change Design/Components/Specifications/Material | supplement_reason |
Source: FDA openFDA, device/pma, P010015/S583, retrieved 2026-09-19 21:55 Eastern. Public domain (CC0).
Product code
The FDA classification record for the code on this record.
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 2026-09-19 21:55 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: 2026-09-20 08:40 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:S583&limit=1
{
"id": "58f43e28-95ad-4784-a577-c2266e67a59c",
"pma_key": "P010015/S583",
"pma_number": "P010015",
"supplement_number": "S583",
"applicant": "Medtronic, Inc.",
"trade_name": "Percepta Bipolar CRT-P (WlTR0l); Percepta Quadripolar CRT-P (W4TR01); Serena Bipolar CRT-P (WlTR02); Serena Quadripolar",
"generic_name": "Implantable pulse generator, pacemaker (non-CRT)",
"product_code": "LWP",
"advisory_committee_description": "Cardiovascular",
"decision_date": "2026-05-14",
"decision_code": "APPR",
"supplement_type": "Real-Time Process",
"supplement_reason": "Change Design/Components/Specifications/Material",
"date_received": "2026-02-13",
"source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P010015&s=S583",
"verified_at": "2026-09-20T02:04:16.808+00:00",
"created_at": "2026-09-20T01:55:41.466163+00:00",
"collected_at": "2026-09-20T01:55:27.157+00:00",
"last_checked_at": null
}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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