ATAKR(TM) RFCA SYSTEM
FDA premarket approval P930029/S004 · decided 1996-09-30
Approval details
- PMA number
- P930029
- Supplement
- S004
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ATAKR(TM) RFCA SYSTEM
- Generic name
- Cardiac ablation percutaneous catheter
- Applicant
- Medtronic, Inc.
- Date received
- 1995-08-30
- Decision date
- 1996-09-30
- Days to decision
- 397 days
- Decision code
- APPR
- Product code
- LPB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR THE ADDTION OF A GRAPH SHOWING THE RELATIONSHIP OF INITIAL ATAKR POWER OUTPUT TO TEMPERATURE SET POINT DURING THE RAMP UP PERIOD IN TEMPERATURE CONTROL MODE AND THE ADDTION OF A WARNING STATEMENT REARDING PROPER CONNECTION TECHNIQURES WHEN UTILIZING THE ATAKR SYSTEM WITH OTHER CATHETER LABORATORY EQUIPMENT
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