Product code

DSR: Stimulator, carotid sinus nerve

FDA product code · Class III · Cardiovascular

Key facts

Product code DSR
Device Stimulator, carotid sinus nerve
Device class Class III
Regulation number 870.3850
Review panel Cardiovascular
Medical specialty Cardiovascular
Submission type PMA
GMP exempt No
Implanted device Yes
Life-sustaining or life-supporting No
Definition Call for PMAs 12/26/96 (61 FR 50706 (9/27/96))

At a glance

  • None 510(k) clearances
  • None De Novo grants
  • 1–9 PMA approvals
  • 1–9 HDE approvals
  • 10–99 UDI devices (GUDID)
  • 100–999 MAUDE adverse event reports
  • None Recalled products (Z-numbers)

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device product codes

FDA product codes classify medical devices by type and intended use; each code maps to a device class, a classification regulation and a review panel.

Source: U.S. Food and Drug Administration (FDA), Product Classification database

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