Product code FHW
- Device name
- Device, Impotence, Mechanical/Hydraulic
- Medical specialty
- Gastroenterology, Urology
- Device class
- 3
- Regulation number
- 876.3350
- Review panel
- GU
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Definition
- PMAs to be filed by 7/11/00 (65 FR 19658 (4/12/00))
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P000006S071 | Titan Inflatable Penile Prosthesis | Coloplast Corp. | 2025-08-14 |
| P000006S070 | Titan Inflatable Penile Prosthesis | Coloplast Corp. | 2025-05-28 |
| P000006S069 | Titan Inflatable Penile Prosthesis (IPP) | Coloplast Corp. | 2024-10-02 |
| P000006S068 | Titan Inflatable Penile Prosthesis (IPP) | Coloplast Corp. | 2024-07-09 |
| P000006S067 | Titan Inflatable Penile Prosthesis (IPP) | Coloplast Corp. | 2024-02-05 |
| P000006S064 | Titan Inflatable Penile Prosthesis (IPP) | Coloplast Corp. | 2023-03-03 |
| P000006S066 | Titan Inflatable Penile Prosthesis (IPP) | Coloplast Corp. | 2023-02-15 |
| P000006S065 | Titan Inflatable Penile Prosthesis (IPP) | Coloplast Corp. | 2023-01-12 |
| P000006S063 | Titan Inflatable Penile Prosthesis (IPP) | Coloplast Corp. | 2022-12-01 |
| P000006S062 | Titan Inflatable Penile Prosthesis (IPP) | Coloplast Corp. | 2022-08-24 |
| P000006S061 | Titan Inflatable Penile Prosthesis (IPP) | Coloplast Corp. | 2022-04-15 |
| P000006S060 | TITAN INFLATABLE PENILE PROSTHESIS | Coloplast Corp. | 2021-12-22 |
| P000006S059 | Titan Inflatable Penile Prosthesis | Coloplast Corp. | 2021-01-08 |
| P000006S058 | Titan Inflatable Penile Prosthesis | Coloplast Corp. | 2020-12-07 |
| P000006S057 | Titan Inflatable Penile Prosthesis | Coloplast Corp. | 2020-10-01 |
| P000006S054 | Titan Inflatable Penile Prosthesis (IPP) | Coloplast Corp. | 2020-07-10 |
| P000006S056 | Titan Inflatable Penile Prosthesis (IPP) | Coloplast Corp. | 2020-06-05 |
| P000006S053 | Titan Inflatable Penile Prosthesis (IPP) | Coloplast Corp. | 2019-10-25 |
| P000006S051 | Titan Inflatable Penile Prosthesis | Coloplast Corp. | 2019-09-05 |
| P000006S052 | Titan Inflatable Penile Prosthesis | Coloplast Corp. | 2019-08-21 |
| P000006S050 | Titan Inflatable Penile Prosthesis (IPP) | Coloplast Corp. | 2018-08-31 |
| P000006S049 | Titan Inflatable Penile Prosthesis (IPP) | Coloplast Corp. | 2018-07-27 |
| P000006S047 | Titan Inflatable Penile Prosthesis | Coloplast Corp. | 2017-09-08 |
| P000006S046 | Titan Inflatable Penile Prosthesis | Coloplast Corp. | 2017-05-17 |
| N970012S111 | AMS 700 INFLATABLE PENILE PROSTHESIS | Boston Scientific Corp | 2016-02-03 |
| P000006S045 | TITAN INFLATABLE PENILE PROSTHESIS | Coloplast Corp. | 2015-11-23 |
| N970012S112 | AMS 700 INFLATABLE PENILE PROSTHESIS | Boston Scientific Corp | 2015-10-30 |
| N970012S113 | AMS 700 AMBICOR INFLATABLE PENILE PROTHESIS | Boston Scientific Corp | 2015-10-14 |
| N970012S110 | AMS 700, AMS AMBICOR, AMS 700 WITH MS PUMP INFLATABLE PENILE PROSTHESIS (IPP) | Boston Scientific Corp | 2015-08-04 |
| P000006S040 | TITAN INFLATABLE PENILE PROSTHESIS | Coloplast Corp. | 2015-04-13 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 05708932778671 | Titan | Coloplast A/S | 2025-10-21 |
| 05708932778701 | True-Lock | Coloplast A/S | 2025-10-21 |
| 05701780278034 | Titan | Coloplast A/S | 2025-07-29 |
| 05708932768115 | Titan Classic | Coloplast A/S | 2024-10-29 |
| 05708932768139 | Titan Classic | Coloplast A/S | 2024-10-29 |
| 05708932768153 | Titan Touch | Coloplast A/S | 2024-10-29 |
| 05708932768177 | Titan Touch | Coloplast A/S | 2024-10-29 |
| 05701780276979 | Titan | Coloplast A/S | 2023-05-11 |
| 05701780277006 | Titan | Coloplast A/S | 2023-05-11 |
| 05708932072601 | Titan® | Coloplast A/S | 2017-10-16 |
| 05708932072649 | Titan® | Coloplast A/S | 2017-10-16 |
| 05708932072632 | Titan® | Coloplast A/S | 2017-10-16 |
| 05708932072595 | Titan® | Coloplast A/S | 2017-10-16 |
| 05708932072557 | Titan® | Coloplast A/S | 2017-10-16 |
| 05708932072526 | Titan® | Coloplast A/S | 2017-10-16 |
| 05708932072519 | Titan® | Coloplast A/S | 2017-10-16 |
| 05708932072564 | Titan® | Coloplast A/S | 2017-10-16 |
| 00878953003023 | Proximal Tool | AMERICAN MEDICAL SYSTEMS, INC. | 2014-09-24 |
| 05708932322584 | Titan | Coloplast A/S | 2014-09-19 |
| 05708932487160 | Titan | Coloplast A/S | 2014-09-19 |
| 05708932487146 | Titan | Coloplast A/S | 2014-09-19 |
| 05708932323901 | Titan | Coloplast A/S | 2014-09-19 |
| 05708932323604 | Titan | Coloplast A/S | 2014-09-19 |
| 05708932322348 | Titan | Coloplast A/S | 2014-09-19 |
| 05708932473910 | Titan | Coloplast A/S | 2014-07-25 |
| 05708932473927 | Titan | Coloplast A/S | 2014-07-25 |
| 05708932319744 | Titan | Coloplast A/S | 2014-07-21 |
| 05708932319621 | Titan | Coloplast A/S | 2014-07-21 |
| 05708932487184 | Titan | Coloplast A/S | 2014-07-21 |
| 05708932487221 | Titan | Coloplast A/S | 2014-07-21 |