Device |
kit, balloon repair, catheter |
Regulation Description |
Catheter balloon repair kit. |
Definition |
Call for PMAs 12/26/96 (61 FR 50706 (9/27/96)) |
Regulation Medical Specialty |
Cardiovascular |
Review Panel |
Cardiovascular |
Product Code | DQP |
Premarket Review |
Office of Cardiovascular Devices
(OHT2)
Coronary and Peripheral Interventional Devices
(DHT2C)
|
Submission Type |
PMA
|
Regulation Number |
870.1350
|
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 |
|
|