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ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM

FDA premarket approval P900056/S082 · decided 2005-02-09

Approval details

PMA number
P900056
Supplement
S082
Supplement type
Real-Time Process
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Trade name
ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM
Generic name
CATHETER, CORONARY, ATHERECTOMY
Applicant
Boston Scientific Corp
Date received
2004-12-27
Decision date
2005-02-09
Days to decision
44 days
Decision code
APPR
Product code
MCX
Advisory committee
Cardiovascular
Expedited review
No
Location
Maple Grove, MN
Statement
APPROVAL FOR CHANGES TO THE DIRECTIONS FOR USE (DFU) MANUAL FOR THE ROTABLATOR CONSOLE UNIT. THE CHANGES INCLUDE REMOVAL OF THE REFERENCES TO THE CONSOLE RECORDER CONNECTION, UPDATES TO THE CONTACT INFORMATION AND CATALOG NUMBERS, AND OTHER MINOR CLARIFICATIONS.

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