PMA P020014S037
- Device
- CONCEPTUS ESSURE SYSTEM
- Applicant
- Bayer Pharma AG
- PMA number
- P020014
- Supplement
- S037
- Product code
- HHS
- Decision date
- 2012-05-17
- Generic name
- Transcervical contraceptive tubal occlusion device
- Approval order statement
- REPLACE THE CURRENT MANUAL DEPLOY AND DETACH TEST FIXTURE WITH AN AUTOMATED TEST FIXTURE FOR LOT RELEASE TESTING OF HE ESSURE SYSTEM.
Current openFDA PMA Record#
- Device
- CONCEPTUS ESSURE SYSTEM
- Applicant
- Bayer Pharma AG
- PMA number
- P020014
- Supplement
- S037
- Product code
- HHS
- Generic name
- Transcervical contraceptive tubal occlusion device
- Decision date
- 2012-05-17
- Decision code
- OK30
- Date received
- 2012-03-05
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- REPLACE THE CURRENT MANUAL DEPLOY AND DETACH TEST FIXTURE WITH AN AUTOMATED TEST FIXTURE FOR LOT RELEASE TESTING OF HE ESSURE SYSTEM.