PMA P020014S024
- Device
- CONCEPTUS ESSURE SYSTEM
- Applicant
- Bayer Pharma AG
- PMA number
- P020014
- Supplement
- S024
- Product code
- HHS
- Decision date
- 2009-08-26
- Generic name
- Transcervical contraceptive tubal occlusion device
- Approval order statement
- APPROVAL FOR AN ALTERNATE SUPPLIER FOR THE WOUND INNER/OUTER COIL (PRECISION WIRE COMPONENTS) OF THE DEVICE.
Current openFDA PMA Record#
- Device
- CONCEPTUS ESSURE SYSTEM
- Applicant
- Bayer Pharma AG
- PMA number
- P020014
- Supplement
- S024
- Product code
- HHS
- Generic name
- Transcervical contraceptive tubal occlusion device
- Decision date
- 2009-08-26
- Decision code
- APPR
- Date received
- 2009-01-30
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR AN ALTERNATE SUPPLIER FOR THE WOUND INNER/OUTER COIL (PRECISION WIRE COMPONENTS) OF THE DEVICE.