PMA P020014S017

Device: CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL
Applicant: Bayer Pharma AG
PMA number: P020014
Supplement: S017
Product code: HHS
Decision date: 2012-02-24
Generic name: Transcervical contraceptive tubal occlusion device
Approval order statement: APPROVAL TO MODIFY THE EXISTING RF ENERGY WARNING TO ADD AN ESSURE/ NOVASURE WARNING. ADDITIONALLY, THE PMA SUPPLEMENT INCLUDES APPROVAL OF A POST-APPROVAL STUDY.

Current openFDA PMA Record#

Device: CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL
Applicant: Bayer Pharma AG
PMA number: P020014
Supplement: S017
Product code: HHS
Generic name: Transcervical contraceptive tubal occlusion device
Decision date: 2012-02-24
Decision code: APPR
Date received: 2008-04-04
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL TO MODIFY THE EXISTING RF ENERGY WARNING TO ADD AN ESSURE/ NOVASURE WARNING. ADDITIONALLY, THE PMA SUPPLEMENT INCLUDES APPROVAL OF A POST-APPROVAL STUDY.