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VITALITY HE, RENEWAL 3 AND RENEWAL 3RF FAMILIES OF ICDS

FDA premarket approval P010012/S117 · decided 2006-04-05

Approval details

PMA number
P010012
Supplement
S117
Supplement type
Real-Time Process
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Trade name
VITALITY HE, RENEWAL 3 AND RENEWAL 3RF FAMILIES OF ICDS
Generic name
Implantable pulse generator, pacemaker (non-CRT)
Applicant
Boston Scientific Corp
Date received
2006-03-06
Decision date
2006-04-05
Days to decision
30 days
Decision code
APPR
Product code
LWP
Advisory committee
Cardiovascular
Expedited review
No
Location
St Paul, MN
Statement
APPROVAL FOR UPDATES TO THE SPECIFICATIONS OF THE DEVICES REGARDING CONFIRMATION OF MEETING HERMETIC AND ARC SUPPRESSION UNDER HIGH VOLTAGE REQUIREMENTS RELATED TO THE ATMOSPHERIC GAS WITHIN THE DEVICE.

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