| Device |
catheter, balloon for retinal reattachment |
| Review Panel |
Ophthalmic |
| Product Code | LOG |
| Premarket Review |
Ophthalmic Devices
(DHT1A)
Ophthalmic Devices
(DHT1A)
|
| Submission Type |
PMA
|
| Device Class |
3
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction Reporting |
Eligible |
| Implanted Device? |
No
|
| Life-Sustain/Support Device? |
No
|
| Third Party Review |
Not Third Party Eligible |
|
|