INTELLATIP MIFI XP- ABLATION CATHETER AND BLAZER PRIME XP CATHETER
FDA premarket approval P020025/S036 · decided 2013-08-07
Approval details
- PMA number
- P020025
- Supplement
- S036
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- INTELLATIP MIFI XP- ABLATION CATHETER AND BLAZER PRIME XP CATHETER
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Applicant
- Boston Scientific
- Date received
- 2012-11-02
- Decision date
- 2013-08-07
- Days to decision
- 278 days
- Decision code
- APPR
- Product code
- OAD
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR BLAZER PRIME XP CATHETER DESIGN MODIFICATIONS, MATERIAL PACKAGING, LABELING CHANGES, AND ADDITION OF ACCESSORIES: INTELLATIP MIFI CABLE, FILTER MODULE, AND REFERENCE CABLE FOR THE INTELLATIP MIFI FAMILY OF CATHETERS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME INTELLATIP MIFI XP ABLATION CATHETER AND IS INDICATED FOR USE WITH THE BSC MAESTRO 3000 CARDIAC ABLATION CONTROLLER AND ACCESSORIES FOR THE TREATMENT OF SUSTAINED OR RECURRENT TYPE I ATRIAL FLUTTER IN PATIEN
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