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BOSTON SCIENTIFIC XP APM (AUTOMATIC PERSONALITY MODULE) UNIT, MODEL 822T

FDA premarket approval P920047/S035 · decided 2006-12-01

Approval details

PMA number
P920047
Supplement
S035
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Trade name
BOSTON SCIENTIFIC XP APM (AUTOMATIC PERSONALITY MODULE) UNIT, MODEL 822T
Generic name
Cardiac ablation percutaneous catheter
Applicant
Boston Scientific Corp
Date received
2006-08-21
Decision date
2006-12-01
Days to decision
102 days
Decision code
APPR
Product code
LPB
Advisory committee
Cardiovascular
Expedited review
No
Location
St Paul, MN
Statement
APPROVAL FOR THE ADDITION OF A CHOKE IN THE XP APM WHICH WILL ELIMINATE THE DELIVERY OF THE RF ENERGY WHERE THE USER FAILED TO CONNECT OR IMPROPERLY CONNECTED THE DISPERSIVE INDIFFERENT PATCH (DIP) ELECTRODES TO THE PATIENT.

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