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S670 WITH DISCRETE TECHNOLOGY OVER THE WIRE CORONARY STENT SYSTEM

FDA premarket approval P970035/S019 · decided 2000-05-11

Approval details

PMA number
P970035
Supplement
S019
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name
S670 WITH DISCRETE TECHNOLOGY OVER THE WIRE CORONARY STENT SYSTEM
Generic name
STENT, CORONARY
Applicant
Medtronic, Ireland
Date received
2000-04-14
Decision date
2000-05-11
Days to decision
27 days
Decision code
OK30
Product code
MAF
Advisory committee
Cardiovascular
Expedited review
No
Location
Galway
Statement
Requesting that the three-step manufacturing process of the distal and intermediate tubing be reduced to a two-step manufacturing process of the distal and intermediate tubing be reduced to a two-step process whereby the forming step will be completely removed and the tubing will be extruded to the final dimensions.

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