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IntellaTip MiFi Xp Ablation Catheters, IntellaNsv MiFi XP Ablation Catheters and IntellaNav ST Ablation Catheters

FDA premarket approval P920047/S114 · decided 2019-04-16

Approval details

PMA number
P920047
Supplement
S114
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name
IntellaTip MiFi Xp Ablation Catheters, IntellaNsv MiFi XP Ablation Catheters and IntellaNav ST Ablation Catheters
Generic name
Cardiac ablation percutaneous catheter
Applicant
Boston Scientific Corp
Date received
2019-03-21
Decision date
2019-04-16
Days to decision
26 days
Decision code
OK30
Product code
LPB
Advisory committee
Cardiovascular
Expedited review
No
Location
St Paul, MN
Statement
Addition of two Thermistor Temperature Accuracy Test Systems for use during the final inspection.

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510(k) clearances by this applicant

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