PMA P020014S015
- Device
- ESSURE SYSTEM
- Applicant
- Bayer Pharma AG
- PMA number
- P020014
- Supplement
- S015
- Product code
- HHS
- Decision date
- 2008-06-10
- Generic name
- Transcervical contraceptive tubal occlusion device
- Approval order statement
- APPROVAL FOR LABELING CHANGES REGARDING CONCOMITANT ESSURE AND ENDOMETRIAL ABLATION PROCEDURES.
Current openFDA PMA Record#
- Device
- ESSURE SYSTEM
- Applicant
- Bayer Pharma AG
- PMA number
- P020014
- Supplement
- S015
- Product code
- HHS
- Generic name
- Transcervical contraceptive tubal occlusion device
- Decision date
- 2008-06-10
- Decision code
- APPR
- Date received
- 2008-02-04
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR LABELING CHANGES REGARDING CONCOMITANT ESSURE AND ENDOMETRIAL ABLATION PROCEDURES.