Product code HHS
- Device name
- Transcervical Contraceptive Tubal Occlusion Device
- Medical specialty
- Obstetrics/Gynecology
- Device class
- 3
- Regulation number
- 884.5380
- Review panel
- OB
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Definition
- Call for PMAs 12/30/87 (52 FR 36883 10/1/87))
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P020014S051 | Essure System for Permanent Birth Control | Bayer Pharma AG | 2018-04-09 |
| P020014S050 | Essure System for Permanent Birth Control | Bayer Pharma AG | 2018-03-22 |
| P020014S049 | Essure System for Permanent Birth Control | Bayer Pharma AG | 2017-12-04 |
| P020014S048 | ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL | Bayer Pharma AG | 2016-12-14 |
| P020014S046 | ESSURE SYSTEM | Bayer Pharma AG | 2016-11-15 |
| P020014S047 | Essure System for Permanent Birth Control (Model ESS305) | Bayer Pharma AG | 2016-09-29 |
| P020014S044 | ESSURE SYSTEM | Bayer Pharma AG | 2016-05-12 |
| P020014S045 | ESSURE SYSTEM | Bayer Pharma AG | 2016-04-28 |
| P020014S041 | ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL | Bayer Pharma AG | 2015-06-29 |
| P020014S043 | ESSURE SYSTEM | Bayer Pharma AG | 2015-06-09 |
| P020014S042 | ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL | Bayer Pharma AG | 2014-12-11 |
| P020014S040 | ESSURE | Bayer Pharma AG | 2013-10-30 |
| P020014S039 | ESSURE SYSTEM | Bayer Pharma AG | 2012-12-20 |
| P020014S038 | CONCEPTUS ESSURE SYSTEM | Bayer Pharma AG | 2012-10-02 |
| P020014S037 | CONCEPTUS ESSURE SYSTEM | Bayer Pharma AG | 2012-05-17 |
| P020014S036 | CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL | Bayer Pharma AG | 2012-04-19 |
| P020014S035 | CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL | Bayer Pharma AG | 2012-03-19 |
| P020014S017 | CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL | Bayer Pharma AG | 2012-02-24 |
| P020014S033 | CONCEPTUS ESSURE SYSTEM | Bayer Pharma AG | 2012-02-22 |
| P020014S034 | CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL | Bayer Pharma AG | 2011-07-01 |
| P020014S032 | CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL | Bayer Pharma AG | 2011-02-24 |
| P020014S029 | CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL | Bayer Pharma AG | 2010-04-06 |
| P020014S030 | CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL | Bayer Pharma AG | 2010-02-15 |
| P020014S024 | CONCEPTUS ESSURE SYSTEM | Bayer Pharma AG | 2009-08-26 |
| P020014S026 | ESSURE SYSTEM | Bayer Pharma AG | 2009-07-16 |
| P020014S027 | CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL | Bayer Pharma AG | 2009-06-19 |
| P020014S025 | CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL | Bayer Pharma AG | 2009-06-11 |
| P020014S022 | CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL | Bayer Pharma AG | 2009-04-20 |
| P020014S018 | CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL | Bayer Pharma AG | 2009-03-16 |
| P020014S023 | CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL | Bayer Pharma AG | 2009-03-09 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00888853030517 | Essure | Bayer Healthcare LLC | 2014-09-04 |
| 10888853003051 | Essure | Bayer Healthcare LLC | 2014-09-04 |
| 20888853003058 | Essure | Bayer Healthcare LLC | 2014-09-04 |