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CONTAK CD/EASYTRAK LEADS & ACCESSORIES

FDA premarket approval P010012/S006 · decided 2002-12-13

Approval details

PMA number
P010012
Supplement
S006
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name
CONTAK CD/EASYTRAK LEADS & ACCESSORIES
Generic name
Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
Applicant
Boston Scientific Corp
Date received
2002-11-13
Decision date
2002-12-13
Days to decision
30 days
Decision code
OK30
Product code
NIK
Advisory committee
Cardiovascular
Expedited review
No
Location
St Paul, MN
Statement
CHANGE IN THE MANUFACTURING PROCESS TO THE PARAMETRIC RELEASE METHOD, WHICH INVOLVES STERILE PRODUCT RELEASE BASED ON CONFORMANCE TO PRE-DEFINED STERILIZATION PARAMETERS RATHER THAN A RELEASE BASED ON DEMONSTRATING NO GROWTH IN BIOLOGICAL INDICATOR.

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510(k) clearances by this applicant

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EndoVive Initial Placement Standard PEG Kit with ENFit Connector, EndoVive Initial Placement Safety PEG Kit with ENFit Connector (K150679)Boston Scientific Corp2015-05-29
JAGWIRE HIGH PERFORMANCE GUIDWIRE (K141820)Boston Scientific Corp2014-10-21