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PTCA CATHETERS, NIR PREMOUNTED STENT DELIVERY SYSTEM, AND EXPRESS/EXPRESS2 CORONARY STENT SYSTEM

FDA premarket approval P980001/S041 · decided 2002-10-23

Approval details

PMA number
P980001
Supplement
S041
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name
PTCA CATHETERS, NIR PREMOUNTED STENT DELIVERY SYSTEM, AND EXPRESS/EXPRESS2 CORONARY STENT SYSTEM
Generic name
STENT, CORONARY
Applicant
Boston Scientific Corp
Date received
2002-09-23
Decision date
2002-10-23
Days to decision
30 days
Decision code
OK30
Product code
MAF
Advisory committee
Cardiovascular
Expedited review
No
Location
Natick,, MA
Statement
CHANGE INVOLVING THE REDUCTION OF BIOSLIDE CURING TIME BY INCREASING THE ALLOWED PERCENT OXYGEN AND LEVEL OF UV EXPOSURE.

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