Atlas FDA

S670 OVER-THE-WIRE CORONARY STENT SYSTEM

FDA premarket approval P970035/S014 · decided 1999-11-16

Approval details

PMA number
P970035
Supplement
S014
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Trade name
S670 OVER-THE-WIRE CORONARY STENT SYSTEM
Generic name
STENT, CORONARY
Applicant
Medtronic, Ireland
Date received
1999-04-21
Decision date
1999-11-16
Days to decision
209 days
Decision code
APPR
Product code
MAF
Advisory committee
Cardiovascular
Expedited review
No
Location
Galway
Statement
Approval for the Medtronic AVE (AVE) S670 with Discrete Technology(TM) Over-The Wire Coronary Stent System. The device is indicated for improving coronary luminal diameter in patients with symptomiatic ischemic heart disease due to discrete de novo lesions (length <30 mm) in native coronary arteries with reference vessel diameters ranging from 3.0 and 4.0 mm. Long term outcome (beyond 14 days) for this permanent implant is unknown at present.

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