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FINISHING WIRE UNIVERSAL , MODEL NUMBERS 6002,6003,6004,6005,6007

FDA premarket approval P010012/S030 · decided 2004-07-21

Approval details

PMA number
P010012
Supplement
S030
Supplement type
Special (Immediate Track)
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Trade name
FINISHING WIRE UNIVERSAL , MODEL NUMBERS 6002,6003,6004,6005,6007
Generic name
Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
Applicant
Boston Scientific Corp
Date received
2004-06-25
Decision date
2004-07-21
Days to decision
26 days
Decision code
APPR
Product code
NIK
Advisory committee
Cardiovascular
Expedited review
No
Location
St Paul, MN
Statement
APPROVAL FOR ADDING INSTRUCTIONS IN THE LABELING TO CONTINUE FLUOROSCOPY DURING REMOVAL OF THE GUIDING CATHETER.

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