9F FREEZOR MAX SURGICAL CARDIAC CRYOABLATION DEVICE
FDA premarket approval P020045/S006 · decided 2004-10-26
Approval details
- PMA number
- P020045
- Supplement
- S006
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- 9F FREEZOR MAX SURGICAL CARDIAC CRYOABLATION DEVICE
- Generic name
- Cardiac ablation percutaneous catheter
- Applicant
- Medtronic Cryocath, LP
- Date received
- 2004-05-10
- Decision date
- 2004-10-26
- Days to decision
- 169 days
- Decision code
- APPR
- Product code
- LPB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR THE 9F FREEZOR MAX SURGICAL CARDIAC CRYOABLATION DEVICE, A MODIFICATION TO THE FREEZOR XTRA CARDIAC CRYOABLATION SYSTEM PREVIOUSLY APPROVED UNDER P020045/S005. THE DEVICE IS INDICATED FOR MINIMALLY INVASIVE CARDIAC SURGERY PROCEDURES, INCLUDING SURGICAL TREATMENT OF CARDIAC ARRHYTHMIAS.
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