e-CFR banner

Home
gpo.gov
govinfo.gov

e-CFR Navigation Aids

Browse

Simple Search

Advanced Search

 — Boolean

 — Proximity

 

Search History

Search Tips

Corrections

Latest Updates

User Info

FAQs

Agency List

Incorporation By Reference

eCFR logo

Related Resources

 

Electronic Code of Federal Regulations

e-CFR data is current as of February 26, 2020

Title 21Chapter ISubchapter HPart 870Subpart D → §870.3850


Title 21: Food and Drugs
PART 870—CARDIOVASCULAR DEVICES
Subpart D—Cardiovascular Prosthetic Devices


§870.3850   Carotid sinus nerve stimulator.

(a) Identification. A carotid sinus nerve stimulator is an implantable device used to decrease arterial pressure by stimulating Hering's nerve at the carotid sinus.

(b) Classification. Class III (premarket approval).

(c) Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before December 26, 1996 for any carotid sinus nerve stimulator that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to a carotid sinus nerve stimulator that was in commercial distribution before May 28, 1976. Any other carotid sinus nerve stimulator shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

[45 FR 7907, Feb. 5, 1980, as amended at 52 FR 17736, May 11, 1987; 61 FR 50706, Sept. 27, 1996]

Need assistance?