Device |
atrial defibrillator |
Regulation Description |
DC-defibrillator (including paddles). |
Definition |
Call for PMAs 12/26/96 (61 FR 50706 9/27/96)) Patients who are icd indicated and who have atrial tachyarrhythmias, or who are at risk of developing atrial tachyarrhythmias. |
Regulation Medical Specialty |
Cardiovascular |
Review Panel |
Cardiovascular |
Product Code | MPC |
Premarket Review |
Office of Cardiovascular Devices
(OHT2)
Cardiac Electrophysiology, Diagnostics, and Monitoring Devices
(DHT2A)
|
Submission Type |
PMA
|
Regulation Number |
870.5300
|
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? |
Yes
|
Recognized Consensus Standard
|
Third Party Review |
Not Third Party Eligible |
|
|