PMA P020014S010

Device: CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL
Applicant: Bayer Pharma AG
PMA number: P020014
Supplement: S010
Product code: HHS
Decision date: 2006-10-11
Generic name: Transcervical contraceptive tubal occlusion device
Approval order statement: APPROVAL FOR MODIFICATION OF THE ESSURE PHYSICIAN AND PATIENT LABELING TO INCLUDE INFORMATION ON THE RESULTS OF THE POSTAPPROVAL STUDY FOR NEWLY TRAINED PHYSICIANS.

Current openFDA PMA Record#

Device: CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL
Applicant: Bayer Pharma AG
PMA number: P020014
Supplement: S010
Product code: HHS
Generic name: Transcervical contraceptive tubal occlusion device
Decision date: 2006-10-11
Decision code: APPR
Date received: 2005-11-23
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Labeling Change - PAS
Approval order statement: APPROVAL FOR MODIFICATION OF THE ESSURE PHYSICIAN AND PATIENT LABELING TO INCLUDE INFORMATION ON THE RESULTS OF THE POSTAPPROVAL STUDY FOR NEWLY TRAINED PHYSICIANS.