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Blazer Open Irrigated Catheter, IntellNav MiFi OI Catheter, IntellaNav OI Catheter, and IntellaTip MiFi OI Catheter, Ste

FDA premarket approval P150005/S070 · decided 2022-02-25

Approval details

PMA number
P150005
Supplement
S070
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name
Blazer Open Irrigated Catheter, IntellNav MiFi OI Catheter, IntellaNav OI Catheter, and IntellaTip MiFi OI Catheter, Ste
Generic name
catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Applicant
Boston Scientific Corp
Date received
2022-01-28
Decision date
2022-02-25
Days to decision
28 days
Decision code
OK30
Product code
OAD
Advisory committee
Cardiovascular
Expedited review
No
Location
St Paul, MN
Statement
Introduction of parametric release for the BSC2000-2 Ethylene Oxide Sterilization Cycle at the BSC Coventry, RI Facility.

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510(k) clearances by this applicant

RecordFirmDate
IceSeed 1.5 CX Straight Needle (H7493968333170); IceSphere1.5 CX Straight Needle (H7493968435730); IceRod 1.5 CX Straight Needle (H7493968535330) (K243245)Boston Scientific Corp2024-10-18
LUX-Dx II (M302); LUX-Dx II+ (M312) (K231328)Boston Scientific Corp2023-08-19
WALLSTENT RP Endoprosthesis Transhepatic Biliary, WALLSTENT Endoprosthesis Transhepatic Biliary (K152853)Boston Scientific Corp2015-11-20
AXIOS Stent with Electrocautery Enhanced Delivery System (K150692)Boston Scientific Corp2015-08-05
XXL Vascular Balloon Dilatation Catheter (K150303)Boston Scientific Corp2015-06-15
Chariot Guiding Sheath (K150186)Boston Scientific Corp2015-06-05
EndoVive Initial Placement Standard PEG Kit with ENFit Connector, EndoVive Initial Placement Safety PEG Kit with ENFit Connector (K150679)Boston Scientific Corp2015-05-29
JAGWIRE HIGH PERFORMANCE GUIDWIRE (K141820)Boston Scientific Corp2014-10-21