Atlas FDA

BLAZER OPEN-IRRIGATED ABLATION CATHETER

FDA premarket approval P150005/S006 · decided 2016-07-05

Approval details

PMA number
P150005
Supplement
S006
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Location Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name
BLAZER OPEN-IRRIGATED ABLATION CATHETER
Generic name
catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Applicant
Boston Scientific Corp
Date received
2016-04-11
Decision date
2016-07-05
Days to decision
85 days
Decision code
APPR
Product code
OAD
Advisory committee
Cardiovascular
Expedited review
No
Location
St Paul, MN
Statement
Approval for a manufacturing site located at Availmed S.A. de C.V. Ave. Industrial 20905 Interior A, Ciudad Industrial, C.P. 22444 Tijuana, Baja California, Mexico.

Class III intelligence, same tools

PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.

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