Definition: PMAs To Be Filed By 7/11/00 (65 FR 19658 (4/12/00))
| Device Type ID | 1943 |
| Device Name | Prosthesis, Penis, Inflatable |
| Regulation Description | Penile Inflatable Implant. |
| Regulation Medical Specialty | Gastroenterology/Urology |
| Review Panel | Gastroenterology/Urology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD) Urology And Lithotripsy Devices Branch (ULDB) |
| Submission Type | PMA |
| CFR Regulation Number | 876.3350 [🔎] |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | JCW |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1943 |
| Device | Prosthesis, Penis, Inflatable |
| Product Code | JCW |
| FDA Device Classification | Class 3 Medical Device |
| Regulation Description | Penile Inflatable Implant. |
| CFR Regulation Number | 876.3350 [🔎] |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 1 |
| Total Device Problems | 1 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | American Medical Systems | II | Jun-25-2015 |
| 2 | American Medical Systems, Inc. | II | Nov-13-2014 |