ATAKR RADIOFREQUENCY CATHETER ABLATION (RFCA) SYSTEM
FDA premarket approval P930029/S012 · decided 1998-08-14
Approval details
- PMA number
- P930029
- Supplement
- S012
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ATAKR RADIOFREQUENCY CATHETER ABLATION (RFCA) SYSTEM
- Generic name
- Cardiac ablation percutaneous catheter
- Applicant
- Medtronic, Inc.
- Date received
- 1998-06-30
- Decision date
- 1998-08-14
- Days to decision
- 45 days
- Decision code
- APPR
- Product code
- LPB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for a manufacturing site located at Medtronic Puerto Rico, Inc., Road 149, Km. 56.3, Villalba, Puerto Rico 00755.
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