Conceptus (CPTS) Labeling Changes for RF NovaSure ICE Ablation Approved by FDA

Conceptus, Inc. (Nasdaq: CPTS), has received an Approvable Letter from the U.S. Food and Drug Administration (FDA) for labeling changes pertaining to the use of bipolar radio frequency (RF) NovaSure Impedance Controlled Endometrial Ablation following a successful Essure Confirmation Test.

In FDA's Approvable Letter, the agency stated that Conceptus' PMA supplement is approvable subject to concurrence with a post-approval study (PAS).

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