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STINGER/STRINGER S/STINGER M/STINGER SM/SCORPION 2/SCORPION 2M ABLATION CATHETERS AND THE TEMPLINK/TEMPLINK M EXTENSION

FDA premarket approval P000020/S014 · decided 2011-03-17

Approval details

PMA number
P000020
Supplement
S014
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name
STINGER/STRINGER S/STINGER M/STINGER SM/SCORPION 2/SCORPION 2M ABLATION CATHETERS AND THE TEMPLINK/TEMPLINK M EXTENSION
Generic name
Cardiac ablation percutaneous catheter
Applicant
Boston Scientific Corp
Date received
2011-01-03
Decision date
2011-03-17
Days to decision
73 days
Decision code
OK30
Product code
LPB
Advisory committee
Cardiovascular
Expedited review
No
Location
Lowell, MA
Statement
ADDITION OF A NEW SUPPLIER FOR CONNECTOR ASSEMBLIES AND PLUG CABLE CONNECTORS.

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