Atlas FDA

CONTAK RENEW 3 RF

FDA premarket approval P010012/S151 · decided 2007-08-24

Approval details

PMA number
P010012
Supplement
S151
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Trade name
CONTAK RENEW 3 RF
Generic name
Implantable pulse generator, pacemaker (non-CRT)
Applicant
Boston Scientific Corp
Date received
2007-06-18
Decision date
2007-08-24
Days to decision
67 days
Decision code
APPR
Product code
LWP
Advisory committee
Cardiovascular
Expedited review
No
Location
St Paul, MN
Statement
APPROVAL FOR THE FOLLOWING CHANGES TO THE CONTAK RENEWAL 3 RF MODELS H210, H215, H217, AND H219: 1) DIGITAL IC PAD CHANGE TO ADDRESS PREMATURE BATTERY DEPLETION. 2) HYBRID MOTHERBOARD DFN TRACE RE-ROUTING FROM OUTSIDE LAYER ?4? TO AN INSIDE LAYER ?3? TO REDUCE ELECTRICAL FIELD INTENSITY AND POSSIBLE ARCING. 3) TRIM TARGET ADJUSTMENT.

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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
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