Cryocor Cryoablation System
FDA premarket approval P050024 · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
PMA numberP050024
Approval
- Applicant
- Boston Scientific Corp
- Received
- July 15, 2005
- Decision date
- August 1, 2007 (APWD)
- Supplements
- 1, latest March 13, 2008
- Product code
- OAD – Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
Approval order statement
APPROVAL FOR THE CRYOCOR CRYOABLATION SYSTEM. THE DEVICE IS INDICATED FOR USE IN THE ABLATION OF ISTHMUS-DEPENDENT RIGHT ATRIAL FLUTTER IN PATIENTS 18 YEARS OF AGE OR OLDER.