Atlas FDA

Blazer Open Irrigated Temperature Ablation Catheter

FDA premarket approval P150005/S053 · decided 2020-05-19

Approval details

PMA number
P150005
Supplement
S053
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Location Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name
Blazer Open Irrigated Temperature Ablation Catheter
Generic name
catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Applicant
Boston Scientific Corp
Date received
2020-03-12
Decision date
2020-05-19
Days to decision
68 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 Boston Scientific Corp. in Ballybrit Business Park Galway, Ireland for sterilization.

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510(k) clearances by this applicant

RecordFirmDate
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EndoVive Initial Placement Standard PEG Kit with ENFit Connector, EndoVive Initial Placement Safety PEG Kit with ENFit Connector (K150679)Boston Scientific Corp2015-05-29
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