Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | STINGER, STINGER S, SCORPION, SCORPION *2 ABLATION CATHETERS AND TEMPLINK EXTENSION CABLES |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | Boston Scientific Corp. 55 TECHNOLOGY DRIVE LOWELL, MA 01851 |
PMA Number | P000020 |
Supplement Number | S012 |
Date Received | 03/31/2009 |
Decision Date | 04/21/2009 |
Withdrawal Date
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01/12/2024 |
Product Code |
LPB |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order 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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