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Data / Medical devices / Pulse Generator, Permanent, Implantable

Pulse Generator, Permanent, Implantable (NVZ): 23 FDA-registered makers in 10 countries

23 establishments in 10 countries are registered with the FDA to make Pulse Generator, Permanent, Implantable (product code NVZ, Class 3). 6 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 20 recall events (2 Class I). FDA data exported November 2, 2026.

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Product code
NVZ
Device class
3
Medical specialty
Unknown
Implant
Yes
Life sustaining or supporting
Yes

Makers by country

CountryMakers
United States12
Singapore2
Malaysia2
Switzerland1
China1
Germany1
Italy1
Mexico1
France1
Taiwan1

Makers of Pulse Generator, Permanent, Implantable

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Medtronic, Inc.Mounds View, MN, United StatesManufacturer, Repackager or relabeler, Specification developer04141api.fda.gov
Medtronic Europe SarlTOLOCHENAZ Vaud, SwitzerlandManufacturer, Repackager or relabeler0300api.fda.gov
Medtronic Sofamor Danek Usa, Inc.Memphis, TN, United StatesManufacturer0200api.fda.gov
Medtronic Puerto Rico Operations Co., JuncosJuncos, PR, United StatesManufacturer0100api.fda.gov
Medtronic Puerto Rico Operations Co., VillalbaVillalba, PR, United StatesManufacturer, Repackager or relabeler0100api.fda.gov
Medtronic Singapore Operations Pte LtdSingapore Central Singapore, SingaporeManufacturer, Repackager or relabeler0100api.fda.gov
Abbott MedicalSylmar, CA, United StatesManufacturer, Manufacturer for export0051api.fda.gov
Abbott MedicalPenang Pulau Pinang, MalaysiaManufacturer0000api.fda.gov
Abbott MedicalArecibo, PR, United StatesManufacturer0000api.fda.gov
Amphenol Medical Technologies (Dongguan) Co., Ltd.Dongguan Guangdong, ChinaContract manufacturer0000api.fda.gov
Benchmark Electronics, Inc.Winona, MN, United StatesContract manufacturer0000api.fda.gov
Biotronik Apm Ii Pte. LtdSingapore South East, SingaporeContract manufacturer0000api.fda.gov
Biotronik Se & Co. KGBerlin, GermanyManufacturer0000api.fda.gov
Boston Scientific CorporationSaint Paul, MN, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Medtronic VascularDanvers, MA, United StatesManufacturer0000api.fda.gov
MicroPort CRM S.r.l.Saluggia (VC) Vercelli, ItalyManufacturer, Repackager or relabeler0000api.fda.gov
Pro-Tech Design & MFG., Inc.Santa Fe Springs, CA, United StatesContract manufacturer0000api.fda.gov
Plexus Electronica S. de R.L. de C.V..Zapopan Jalisco, MexicoContract manufacturer0000api.fda.gov
Plexus Manufacturing Sdn. Bhd.Bayan Lepas Pulau Pinang, MalaysiaContract manufacturer0000api.fda.gov
Respicardia, Inc.Minnetonka, MN, United StatesManufacturer for export, Specification developer0000api.fda.gov
Sorin CRM SASCLAMART Hauts-de-Seine, FranceComplaint file establishment, Repackager or relabeler, Specification developer0000api.fda.gov
Technical Services For Electronics, Inc.Jackson, MN, United StatesContract manufacturer0000api.fda.gov
Technical Services for Electronics, Inc.New Taipei City, TaiwanContract manufacturer0000api.fda.gov

Updated November 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.