Device |
device, impotence, mechanical/hydraulic |
Regulation Description |
Penile inflatable implant. |
Definition |
PMAs to be filed by 7/11/00 (65 FR 19658 (4/12/00)) |
Regulation Medical Specialty |
Gastroenterology/Urology |
Review Panel |
Gastroenterology/Urology |
Product Code | FHW |
Premarket Review |
Reproductive, Gynecology and Urology Devices
(DHT3B)
Reproductive, Gynecology and Urology Devices
(DHT3B)
|
Submission Type |
PMA
|
Regulation Number |
876.3350
|
Device Class |
3
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Ineligible |
Implanted Device? |
Yes
|
Life-Sustain/Support Device? |
No
|
Third Party Review |
Not Third Party Eligible |
|
|