Stimulator, Carotid Sinus Nerve

Device Code: 773

Product Code(s): DSR

Definition: Call For PMAs 12/26/96 (61 FR 50706 (9/27/96))

Device Classification Information

• Device Type ID: 773
• Device Name: Stimulator, Carotid Sinus Nerve
• Regulation Description: Carotid Sinus Nerve Stimulator.
• Regulation Medical Specialty: Cardiovascular
• Review Panel: Cardiovascular
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Cardiovascular Devices (DCD); Implantable Electrophysical Devices Branch (IEDB)
• Submission Type: PMA
• CFR Regulation Number: 870.3850 [🔎]
• FDA Device Classification: Class 3 Medical Device
• Product Code: DSR
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: Yes
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

• Device Type ID: 773
• Device: Stimulator, Carotid Sinus Nerve
• Product Code: DSR
• FDA Device Classification: Class 3 Medical Device
• Regulation Description: Carotid Sinus Nerve Stimulator.
• CFR Regulation Number: 870.3850 [🔎]

Device Problems
Fracture	1
Adverse Event Without Identified Device Or Use Problem	1
Total Device Problems	2

TPLC Last Update: 2019-04-02 19:41:04