PMA P020014S040
- Device
- ESSURE
- Applicant
- Bayer Pharma AG
- PMA number
- P020014
- Supplement
- S040
- Product code
- HHS
- Decision date
- 2013-10-30
- Generic name
- Transcervical contraceptive tubal occlusion device
- Approval order statement
- APPROVAL FOR CHANGES TO THE PATIENT INFORMATION BOOKLET TO INCLUDE ADDITIONAL INFORMATION ON RISKS OF CHRONIC PELVIC PAIN AND DEVICE MIGRATION.
Current openFDA PMA Record#
- Device
- ESSURE
- Applicant
- Bayer Pharma AG
- PMA number
- P020014
- Supplement
- S040
- Product code
- HHS
- Generic name
- Transcervical contraceptive tubal occlusion device
- Decision date
- 2013-10-30
- Decision code
- APPR
- Date received
- 2013-10-03
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR CHANGES TO THE PATIENT INFORMATION BOOKLET TO INCLUDE ADDITIONAL INFORMATION ON RISKS OF CHRONIC PELVIC PAIN AND DEVICE MIGRATION.