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CONTAK RENEWAL 3 RF CRT-D SYSTEM

FDA premarket approval P010012/S044 · decided 2005-08-15

Approval details

PMA number
P010012
Supplement
S044
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Trade name
CONTAK RENEWAL 3 RF CRT-D SYSTEM
Generic name
Implantable pulse generator, pacemaker (non-CRT)
Applicant
Boston Scientific Corp
Date received
2005-03-04
Decision date
2005-08-15
Days to decision
164 days
Decision code
APPR
Product code
LWP
Advisory committee
Cardiovascular
Expedited review
No
Location
St Paul, MN
Statement
APPROVAL FOR CONTAK RENEWAL 3 RF PULSE GENERATOR SOFTWARE VERSION 1.2 AND CONSULT PROGRAMMER SOFTWARE APPLICATION MODEL 2845 VERSION 4.12. ALSO APPROVAL TO REPLACE THE EXISTING POLYIMIDE TUBING THAT PROVIDES INSULATION IN THE PULSE GENERATOR HEADER ASSEMBLY WITH POLYETHERETHERKE-TONE (PEEK) TUBING.

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