Atlas FDA

CONTAK RENEWAL FAMILY OF CRT-D

FDA premarket approval P010012/S183 · decided 2009-07-30

Approval details

PMA number
P010012
Supplement
S183
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Trade name
CONTAK RENEWAL FAMILY OF CRT-D
Generic name
Implantable pulse generator, pacemaker (non-CRT)
Applicant
Boston Scientific Corp
Date received
2008-06-19
Decision date
2009-07-30
Days to decision
406 days
Decision code
APPR
Product code
LWP
Advisory committee
Cardiovascular
Expedited review
No
Location
St Paul, MN
Statement
APPROVAL FOR THE PROGRAMMER SOFTWARE APPLICATION MODEL 2845 VERSION 4.34 FOR THE CONTAK RENEWAL (MODEL H135), CONTAK RENEWAL 3 (MODELS H170, H175), CONTAK RENEWAL 3 HE (MODELS H177, H179), CONTAK RENEWAL 3 RF (MODELS H210, H215, H250, H255), AND CONTAK RENEWAL 3 RF HE (MODELS H217, H219, H257, H259).

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510(k) clearances by this applicant

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WALLSTENT RP Endoprosthesis Transhepatic Biliary, WALLSTENT Endoprosthesis Transhepatic Biliary (K152853)Boston Scientific Corp2015-11-20
AXIOS Stent with Electrocautery Enhanced Delivery System (K150692)Boston Scientific Corp2015-08-05
XXL Vascular Balloon Dilatation Catheter (K150303)Boston Scientific Corp2015-06-15
Chariot Guiding Sheath (K150186)Boston Scientific Corp2015-06-05
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