K864155

Substantially Equivalent

MODIFICATION OF CARPENTIER-EDWARDS BIOPROSTHESIS

Applicant
American Edwards Laboratories
Product code
DTJ
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Santa Ana, CA, US
Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.