Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
Device class 3 · Review panel CV
FDA PMA supplement record
P010012/S610
EasyTrak, Acuity Spiral and Acuity x4 Leads: ACuity Spiral Lead Model: 4592 Acuity x4 Lead Models: 4671, 4672, 4674, 467 (truncated in the FDA record)
Supplement S610 to premarket approval P010012. Product code NIK. Decision 3 June 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 | P010012 | pma_number |
| Supplement number | S610 | supplement_number |
| Applicant | Boston Scientific Corp | applicant |
| Trade name | EasyTrak, Acuity Spiral and Acuity x4 Leads: ACuity Spiral Lead Model: 4592 Acuity x4 Lead Models: 4671, 4672, 4674, 467 (truncated in the FDA record) | trade_name |
| Generic name | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) | generic_name |
| Product code | NIK | product_code |
| Advisory committee | Cardiovascular | advisory_committee_description |
| Date received | 2026-05-05 | date_received |
| Decision date | 2026-06-03 | decision_date |
| Decision code | OK30 | decision_code |
| Supplement type | 30-Day Notice | supplement_type |
| Supplement reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier | supplement_reason |
Source: FDA openFDA, device/pma, P010012/S610, 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
NIK 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 |
|---|---|---|---|
| P010012 FDA | original approval | empty | 2002-05-02 |
| P010012/S612 FDA | Real-Time Process | Change Design/Components/Specifications/Material | 2026-08-25 |
| P010012/S613 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2026-07-23 |
| P010012/S607 FDA | Real-Time Process | Change Design/Components/Specifications/Material | 2026-07-01 |
| P010012/S611 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2026-06-09 |
| P010012/S610 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2026-06-03 |
| P010012/S609 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2026-06-03 |
| P010012/S608 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2026-05-15 |
| P010012/S606 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2026-04-22 |
| P010012/S594 FDA | Normal 180 Day Track | Change Design/Components/Specifications/Material | 2026-04-21 |
| P010012/S604 FDA | Real-Time Process | Labeling Change - Indications/instructions/shelf life/tradename | 2026-04-10 |
| P010012/S605 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2026-04-01 |
| P010012/S602 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2026-02-13 |
| P010012/S592 FDA | 135 Review Track For 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2026-01-08 |
Source: FDA openFDA, device/pma, records of P010012, retrieved 2026-09-19 21:55 Eastern. 14 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: 2026-09-20 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:P010012+AND+supplement_number:S610&limit=1
{
"id": "25193f0a-7c8f-4500-9146-618f3aee32d1",
"pma_key": "P010012/S610",
"pma_number": "P010012",
"supplement_number": "S610",
"applicant": "Boston Scientific Corp",
"trade_name": "EasyTrak, Acuity Spiral and Acuity x4 Leads: ACuity Spiral Lead Model: 4592 Acuity x4 Lead Models: 4671, 4672, 4674, 467",
"generic_name": "Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)",
"product_code": "NIK",
"advisory_committee_description": "Cardiovascular",
"decision_date": "2026-06-03",
"decision_code": "OK30",
"supplement_type": "30-Day Notice",
"supplement_reason": "Process Change - Manufacturer/Sterilizer/Packager/Supplier",
"date_received": "2026-05-05",
"source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P010012&s=S610",
"verified_at": "2026-09-20T02:04:12.752+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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