Product code EZY
- Device name
- Device, Incontinence, Mechanical/Hydraulic
- Medical specialty
- Gastroenterology, Urology
- Device class
- 3
- Regulation number
- 876.5280
- Review panel
- GU
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Definition
- PMA to be filed by 12/26/00 (65 FR 57731 (9/26/00))
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P000053S141 | AMS 800™ Artificial Urinary Sphincter (AUS) | Boston Scientific Corp | 2026-02-25 |
| P130018S006 | ProACT Adjustable Continence Therapy for Men | Uromedica, Inc. | 2026-02-11 |
| P130018S005 | ProACT™ Adjustable Continence Therapy for Men | Uromedica, Inc. | 2026-01-28 |
| P130018S004 | ProACT™ Adjustable Continence Therapy for Men | Uromedica, Inc. | 2025-10-03 |
| P000053S140 | AMS 800 Artificial Urinary Sphincter (AUS) | Boston Scientific Corp | 2025-07-14 |
| P000053S137 | AMS 800 Artificial Urinary Sphincter (AUS) with and without lnhibiZone | Boston Scientific Corp | 2025-06-03 |
| P000053S139 | AMS 800™ Artificial Urinary Sphincter (AUS) | Boston Scientific Corp | 2025-05-28 |
| P130018S003 | ProACT Adjustable Continence Therapy for Men | Uromedica, Inc. | 2025-05-20 |
| P000053S136 | AMS 800™ Artificial Urinary Sphincter, AMS 800™ Artificial Urinary Sphincter with InhibiZone™ | Boston Scientific Corp | 2025-01-23 |
| P000053S130 | AMS 800 Artificial Urinary Sphincter (with and without InhibiZone) | Boston Scientific Corp | 2024-10-08 |
| P000053S135 | AMS 800™ Artificial Urinary Sphincter with and without InhibiZone™ | Boston Scientific Corp | 2024-05-29 |
| P000053S134 | AMS 800 Artificial Urinary Sphincter (with InhibiZone) | Boston Scientific Corp | 2024-05-23 |
| P000053S133 | AMS 800™ Artificial Urinary Sphincter (AUS) | Boston Scientific Corp | 2023-12-11 |
| P000053S132 | AMS 800 ™ Artificial Urinary Sphincter (AUS) with and without lnhibiZone | Boston Scientific Corp | 2023-11-22 |
| P000053S131 | AMS 800™ Artificial Urinary Sphincter with InhibiZone™ | Boston Scientific Corp | 2023-06-28 |
| P000053S129 | AMS 800 Artificial Urinary Sphincter (AUS) with and without InhibiZone™ | Boston Scientific Corp | 2023-02-23 |
| P000053S128 | AMS 800™ Artificial Urinary Sphincter (AUS) with and without InhibiZone™ | Boston Scientific Corp | 2022-11-14 |
| P000053S127 | AMS 800™ Artificial Urinary Sphincter (AUS) with and without lnhibiZone™ Treatment | Boston Scientific Corp | 2022-09-01 |
| P000053S126 | AMS 800 Artificial Urinary Sphincter, AMS 800 Artificial Urinary Sphincter with InhibiZone Treatment | Boston Scientific Corp | 2022-07-06 |
| P000053S125 | AMS 800™ Artificial Urinary Sphincter, AMS 800™ Artificial Urinary Sphincter with InhibiZone™ | Boston Scientific Corp | 2022-04-20 |
| P000053S124 | AMS 800™ Artificial Urinary Sphincter, AMS 800™ Artificial Urinary Sphincter with InhibiZone™ | Boston Scientific Corp | 2022-04-01 |
| P000053S123 | AMS 800 Artificial Urinary Sphincter with InhibiZone™ | Boston Scientific Corp | 2022-03-07 |
| P000053S121 | AMS 800 Artificial Urinary Sphincter (AUS) with and without InhibiZone Treatment | Boston Scientific Corp | 2021-07-08 |
| P130018S002 | ProACT Adjustable Continence Therapy for Men | Uromedica, Inc. | 2021-06-10 |
| P000053S120 | AMS 800 Series Product Line/Artificial Urinary Sphincter with and without InhibiZone Treatment | Boston Scientific Corp | 2021-05-27 |
| P000053S119 | AMS 800 Artificial Urinary Sphincter | Boston Scientific Corp | 2020-12-17 |
| P000053S118 | AMS 800 Artificial Urinary Sphincter (AUS) with and without InhibiZone Treatment | Boston Scientific Corp | 2020-12-11 |
| P000053S117 | AMS 800 Artificial Urinary Sphincter with and without InhibiZone Treatment | Boston Scientific Corp | 2020-10-30 |
| P000053S116 | AMS 800 Artificial Urinary Sphincter (AUS) with InhibiZone Treatment | Boston Scientific Corp | 2020-09-17 |
| P000053S115 | AMS 800 Artificial Urinary Sphincter and AMS 800 Artificial Urinary Sphincter with InhibiZone Treatment | Boston Scientific Corp | 2020-08-26 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00878953000794 | AMS 800 Artificial Urinary Sphincter | BOSTON SCIENTIFIC CORPORATION | 2014-09-24 |
| 00878953003160 | AMS 800 Artificial Urinary Sphincter | BOSTON SCIENTIFIC CORPORATION | 2014-09-24 |
| 00878953003153 | AMS 800 Artificial Urinary Sphincter | BOSTON SCIENTIFIC CORPORATION | 2014-09-24 |
| 00878953003146 | AMS 800 Artificial Urinary Sphincter | BOSTON SCIENTIFIC CORPORATION | 2014-09-24 |
| 00878953003139 | AMS 800 Artificial Urinary Sphincter | BOSTON SCIENTIFIC CORPORATION | 2014-09-24 |
| 00878953003122 | AMS 800 Artificial Urinary Sphincter | BOSTON SCIENTIFIC CORPORATION | 2014-09-24 |
| 00878953003115 | AMS 800 Artificial Urinary Sphincter | BOSTON SCIENTIFIC CORPORATION | 2014-09-24 |
| 00878953003108 | AMS 800 Artificial Urinary Sphincter | BOSTON SCIENTIFIC CORPORATION | 2014-09-24 |
| 00878953003092 | AMS 800 Artificial Urinary Sphincter | BOSTON SCIENTIFIC CORPORATION | 2014-09-24 |
| 00878953003085 | AMS 800 Artificial Urinary Sphincter | BOSTON SCIENTIFIC CORPORATION | 2014-09-24 |
| 00878953003078 | AMS 800 Artificial Urinary Sphincter | BOSTON SCIENTIFIC CORPORATION | 2014-09-24 |
| 00878953001036 | AMS 800 Artificial Urinary Sphincter | AMERICAN MEDICAL SYSTEMS, INC. | 2014-09-24 |
| 00878953000824 | AMS 800 Artificial Urinary Sphincter | BOSTON SCIENTIFIC CORPORATION | 2014-09-24 |
| 00878953000817 | AMS 800 Artificial Urinary Sphincter | BOSTON SCIENTIFIC CORPORATION | 2014-09-24 |
| 00878953000800 | AMS 800 Artificial Urinary Sphincter | BOSTON SCIENTIFIC CORPORATION | 2014-09-24 |
| 00878953000602 | AMS 800 Artificial Urinary Sphincter | AMERICAN MEDICAL SYSTEMS, INC. | 2014-09-24 |
| 00878953000787 | AMS 800 Artificial Urinary Sphincter | BOSTON SCIENTIFIC CORPORATION | 2014-09-24 |
| 00878953000770 | AMS 800 Artificial Urinary Sphincter | BOSTON SCIENTIFIC CORPORATION | 2014-09-24 |
| 00878953000763 | AMS 800 Artificial Urinary Sphincter | BOSTON SCIENTIFIC CORPORATION | 2014-09-24 |
| 00878953000756 | AMS 800 Artificial Urinary Sphincter | BOSTON SCIENTIFIC CORPORATION | 2014-09-24 |
| 00878953000749 | AMS 800 Artificial Urinary Sphincter | BOSTON SCIENTIFIC CORPORATION | 2014-09-24 |
| 00878953000732 | AMS 800 Artificial Urinary Sphincter | BOSTON SCIENTIFIC CORPORATION | 2014-09-24 |
| 00878953000725 | AMS 800 Artificial Urinary Sphincter | BOSTON SCIENTIFIC CORPORATION | 2014-09-24 |
| 00878953000718 | AMS 800 Artificial Urinary Sphincter | BOSTON SCIENTIFIC CORPORATION | 2014-09-24 |
| 00878953000688 | AMS 800 Artificial Urinary Sphincter | BOSTON SCIENTIFIC CORPORATION | 2014-09-24 |
| 00878953000657 | AMS 800 Artificial Urinary Sphincter | AMERICAN MEDICAL SYSTEMS, INC. | 2014-09-24 |
| 00878953000640 | AMS 800 Artificial Urinary Sphincter | AMERICAN MEDICAL SYSTEMS, INC. | 2014-09-24 |
| 00878953000633 | AMS 800 Artificial Urinary Sphincter | BOSTON SCIENTIFIC CORPORATION | 2014-09-24 |
| 00878953000626 | AMS 800 Artificial Urinary Sphincter | BOSTON SCIENTIFIC CORPORATION | 2014-09-24 |
| 00878953000619 | AMS 800 Artificial Urinary Sphincter | BOSTON SCIENTIFIC CORPORATION | 2014-09-24 |