openFDA Device Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall
event_date_initiated coverage
June 01, 1997–June 30, 2026
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
device · product 1 of 1
Medtronic, Activa PC, Model 37601, Method of Sterilization: Ethylene Oxide, Single Use Only, Rx Only. The Activa¿ PC neurostimulator is a dual-channel device capable of delivering bilateral stimulation. Activa PC contains a non-rechargeable battery and microelectronic circuitry to deliver a controlled electrical pulse to precisely targeted areas of the brain. The device is typically implanted subcutaneously near the clavicle, connected to an extension and leads, which are implanted in the brain.
Medtronic is recalling six Activa PC (model 37601) Implantable Neurostimulators due to the potential for a damaged electrical component during manufacturing.
These labels are deterministic app interpretations, not FDA categories.
Medtronic is recalling six Activa PC (model 37601) Implantable Neurostimulators due to the potential for a damaged electrical component during manufacturing.
Code information
Serial numbers: NKM724776H, NKM724782H, NKM724785H, NKM724790H, NKM724802H, NKM724843H.
