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ROTATIONAL ANGIOPLASTY SYSTEM WITH ROTALINK PLUS EXCHANGEABLE CATHETER/ADVANCER

FDA premarket approval P900056/S056 · decided 2000-10-24

Approval details

PMA number
P900056
Supplement
S056
Supplement type
Normal 180 Day Track
Supplement reason
Location Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name
ROTATIONAL ANGIOPLASTY SYSTEM WITH ROTALINK PLUS EXCHANGEABLE CATHETER/ADVANCER
Generic name
CATHETER, CORONARY, ATHERECTOMY
Applicant
Boston Scientific Corp
Date received
2000-09-29
Decision date
2000-10-24
Days to decision
25 days
Decision code
APPR
Product code
MCX
Advisory committee
Cardiovascular
Expedited review
No
Location
Maple Grove, MN
Statement
APPROVAL FOR AN ADDITIONAL MANUFACTURING SITE LOCATED AT BOSTON SCIENTIFIC CORK LTD., CORK, IRELAND AND AN ADDITIONAL STERILIZATION FACILITY LOCATED AT ISOTRON IRELAND LTD., OFFALY, IRELAND.

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