Product code MIP
- Device name
- Implanted Fecal Incontinence Device
- Medical specialty
- Unknown
- Device class
- 3
- Review panel
- GU
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Definition
- PMA Approved: P010020
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P010020S029 | AMS ACTICON NEOSPHINCTER ARTIFICIAL BOWEL SPHINCTER (ABS) | Boston Scientific Corp | 2016-02-04 |
| P010020S033 | ACTICON NEOSPHINCTER ARTIFICIAL BOWEL SPHINCTER | Boston Scientific Corp | 2015-06-24 |
| P010020S032 | AMS ACTICON NEOSPHINCTER- ARTIFICIAL BOWL SPHINCTER (ABS) | Boston Scientific Corp | 2015-05-06 |
| P010020S031 | AMS ACTICON NEOSPHINCTER | Boston Scientific Corp | 2015-04-15 |
| P010020S030 | AMS ACTICON NEOSPHINCTER- ARTIFICIAL BOWEL SPHINCTER (ABS) | Boston Scientific Corp | 2015-04-08 |
| P010020S028 | AMS ACTION NEOSPHINCTER ARTIFICIAL BOWL SPHINCTER (ABS) | Boston Scientific Corp | 2014-11-18 |
| P010020S027 | AMS ACTICON NEOSPHINCTER-ARTIFICIAL BOWL SPHINCTER (ABS) | Boston Scientific Corp | 2013-02-06 |
| P010020S026 | AMS ACTICON NEOPHINCTER | Boston Scientific Corp | 2012-10-05 |
| P010020S024 | ACTICON NEOSPHINCTER | Boston Scientific Corp | 2012-09-04 |
| P010020S025 | ACTICON NEOSPHINCTER | Boston Scientific Corp | 2012-08-02 |
| P010020S017 | ACTICON NEOSPHINTER | Boston Scientific Corp | 2012-05-07 |
| P010020S023 | ACTICON NEOSPHINCTER | Boston Scientific Corp | 2012-05-02 |
| P010020S022 | ACTICON NEOSPHINCTER | Boston Scientific Corp | 2012-04-26 |
| P010020S021 | ACTICON NEOSPHINCTER | Boston Scientific Corp | 2011-10-26 |
| P010020S020 | ACTICON NEOSPHINCTER | Boston Scientific Corp | 2010-12-22 |
| P010020S019 | ACTICON NEOSPHINCTER ARTIFICIAL BOWEL SPHINCTER | Boston Scientific Corp | 2010-12-16 |
| P010020S018 | ACTICON NEOSPHINCTER | Boston Scientific Corp | 2010-12-15 |
| P010020S015 | ACTICON NEOSPHINCTER ARTIFICIAL BOWEL SPHINCTER | Boston Scientific Corp | 2010-04-23 |
| P010020S014 | ACTICON NEOSPHINCTER ARTIFICAL BOWEL SPHINCTER | Boston Scientific Corp | 2009-08-13 |
| P010020S013 | ACTICON ARTIFICAL BOWEL SPHINCTER (ABS) | Boston Scientific Corp | 2009-04-08 |
| P010020S012 | ACTICON NEOSPHINCTER ARTIFICAL BOWEL SPHINCTER | Boston Scientific Corp | 2009-02-13 |
| P010020S011 | ACTICON ARTIFICIAL BOWEL SPHINCTER | Boston Scientific Corp | 2008-10-09 |
| P010020S010 | ACTICON NEOSPHINCTER ARTIFICIAL BOWEL SPHINCTER | Boston Scientific Corp | 2008-08-08 |
| P010020S009 | ACTICON NEOSPHINCTER ARTIFICIAL BOWEL SPHINCTER | Boston Scientific Corp | 2008-05-30 |
| P010020S006 | ACTICON NEOSPHINCTER ARTIFICAL BOWEL SPHINCTER | Boston Scientific Corp | 2008-04-16 |
| P010020S008 | ACTICON NEOSPHINCTER ARTIFICAL BOWEL SPINCTER | Boston Scientific Corp | 2008-02-05 |
| P010020S007 | ACTICON ARTIFICIAL BOWEL SPHINCTER | Boston Scientific Corp | 2007-10-24 |
| P010020S005 | ACTICON NEOSPHINCTER ARTIFICIAL BOWEL SPHINCTER | Boston Scientific Corp | 2007-07-27 |
| P010020S004 | ACTICON NEOSPHINCTER ARTIFICIAL BOWEL SPHINCTER | Boston Scientific Corp | 2007-04-17 |
| P010020S002 | AMS ACTICON NEOSPHINCTER | Boston Scientific Corp | 2006-12-21 |