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ROTABLATOR SYSTEM/ROTALINK PLUS/ROTALINK ADVANCER & EXCHANGEABLE CATHETER

FDA premarket approval P900056/S099 · decided 2010-08-13

Approval details

PMA number
P900056
Supplement
S099
Supplement type
135 Review Track For 30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name
ROTABLATOR SYSTEM/ROTALINK PLUS/ROTALINK ADVANCER & EXCHANGEABLE CATHETER
Generic name
CATHETER, CORONARY, ATHERECTOMY
Applicant
Boston Scientific Corp
Date received
2010-03-08
Decision date
2010-08-13
Days to decision
158 days
Decision code
APPR
Product code
MCX
Advisory committee
Cardiovascular
Expedited review
No
Location
Maple Grove, MN
Statement
APPROVAL FOR: 1) CHANGE FROM IN-HOUSE MOULDING OF FOUR COMPONENTS TO AN OUTSOURCED MOULDING VENDOR; 2) A CHANGE IN THE MOULDING GATE DESIGN AND LOCATION; 3) CHANGE IN MOULDING MACHINE; AND 4) CHANGE IN THE INSPECTION PROCESS FOR THE COMPONENTS.

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