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STINGER, STINGER S, SCORPION, SCORPION *2 ABLATION CATHETERS AND TEMPLINK EXTENSION CABLES

FDA premarket approval P000020/S012 · decided 2009-04-21

Approval details

PMA number
P000020
Supplement
S012
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Trade name
STINGER, STINGER S, SCORPION, SCORPION *2 ABLATION CATHETERS AND TEMPLINK EXTENSION CABLES
Generic name
Cardiac ablation percutaneous catheter
Applicant
Boston Scientific Corp
Date received
2009-03-31
Decision date
2009-04-21
Days to decision
21 days
Decision code
APPR
Product code
LPB
Advisory committee
Cardiovascular
Expedited review
No
Location
Lowell, MA
Statement
APPROVAL FOR USE OF THE STINGER, STINGER S, SCORPION, SCORPION *2 ABLATION CATHETERS WITH THE BOSTON SCIENTIFIC MAESTRO 3000, EPT-1000XP, AND IRVINE BIOMEDICAL IBI-1500 T9 AND IBI-150 T6 RF GENERATORS.

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