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EASYTRAK IS-1 LEAD, MODELS 4535, 4536, 4537, 4538; EASYTRAK 1 LEAD MODELS 4510, 4511, 4512, 4513

FDA premarket approval P010012/S022 · decided 2004-02-12

Approval details

PMA number
P010012
Supplement
S022
Supplement type
Special (Immediate Track)
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Trade name
EASYTRAK IS-1 LEAD, MODELS 4535, 4536, 4537, 4538; EASYTRAK 1 LEAD MODELS 4510, 4511, 4512, 4513
Generic name
Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
Applicant
Boston Scientific Corp
Date received
2004-01-16
Decision date
2004-02-12
Days to decision
27 days
Decision code
APPR
Product code
NIK
Advisory committee
Cardiovascular
Expedited review
No
Location
St Paul, MN
Statement
APPROVAL TO MODIFY LEAD MANUALS.

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