THERAPY COOL FLEX ABLATION CATHETER
FDA premarket approval P110016/S008 · decided 2013-12-18
Approval details
- PMA number
- P110016
- Supplement
- S008
- Supplement type
- Panel Track
- Trade name
- THERAPY COOL FLEX ABLATION CATHETER
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Applicant
- ABBOTT MEDICAL
- Date received
- 2013-04-01
- Decision date
- 2013-12-18
- Days to decision
- 261 days
- Decision code
- APPR
- Product code
- OAD
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Plymouth, MN
- Statement
- APPROVAL FOR THE THERAPY COOL FLEX ABLATION CATHETER. THIS DEVICE IS INDICATED FOR USE WITH THE COMPATIBLE IRRIGATION PUMP AND 1500T9-CP RADIOFREQUENCY (RF) GENERATOR AT A MAXIMUM OF 50 WATTS. THE CATHETER IS INTENDED FOR CREATING ENDOCARDIAL LESIONS DURING CARDIAC ABLATION PROCEDURES (MAPPING, STIMULATION AND ABLATION) FOR THE TREATMENT OF TYPICAL ATRIAL FLUTTER.
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