BLAZER PRIME XP CARDIAC ABLATION CATHETERS
FDA premarket approval P020025/S020 · decided 2009-10-02
Approval details
- PMA number
- P020025
- Supplement
- S020
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- BLAZER PRIME XP CARDIAC ABLATION CATHETERS
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Applicant
- Boston Scientific
- Date received
- 2009-04-06
- Decision date
- 2009-10-02
- Days to decision
- 179 days
- Decision code
- APPR
- Product code
- OAD
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR CHANGES IN THE STEERING SUBASSEMBLY CENTER SUPPORT AND LEAF SPRINGS, DISTAL TUBING, ADDITION OF A STIFFENING ELEMENT TO THE PROXIMAL SHAFT, MINOR LABELING CHANGES, AND PACKAGING CHANGES, AND THE ADDITION OF A STERILIZATION FACILITY, STERIS ISOMEDIX CORPORATION, SOUTH PLAINFIELD, NEW JERSEY.
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