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CONTAK RENEWAL, CONTAK RENEWAL 3, CONTAK RENEWAL 3 RF CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR SYSTEMS

FDA premarket approval P010012/S131 · decided 2006-08-25

Approval details

PMA number
P010012
Supplement
S131
Supplement type
Normal 180 Day Track
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Trade name
CONTAK RENEWAL, CONTAK RENEWAL 3, CONTAK RENEWAL 3 RF CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR SYSTEMS
Generic name
Implantable pulse generator, pacemaker (non-CRT)
Applicant
Boston Scientific Corp
Date received
2006-05-12
Decision date
2006-08-25
Days to decision
105 days
Decision code
APPR
Product code
LWP
Advisory committee
Cardiovascular
Expedited review
No
Location
St Paul, MN
Statement
APPROVAL FOR PRODUCT RELIABILITY TEST TO BE ADDED TO THE PHYSICIAN AND PATIENT LABELING AS WELL AS OTHER MINOR CHANGES TO THE PATIENT MANUALS.

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