Atlas FDA

PROCROSS RELY SP PTCA CATHETER

FDA premarket approval P790017/S063 · decided 1997-08-26

Approval details

PMA number
P790017
Supplement
S063
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Trade name
PROCROSS RELY SP PTCA CATHETER
Generic name
Catheters, transluminal coronary angioplasty, percutaneous
Applicant
Medtronic, Ireland
Date received
1997-07-31
Decision date
1997-08-26
Days to decision
26 days
Decision code
APPR
Product code
LOX
Advisory committee
Cardiovascular
Expedited review
No
Location
Galway
Statement
Approval for the addition of ten models to your currently marketed line of USCI(R) ProCross(TM) Over-the-Wire Balloon Dilatation Catheters with Hydro/Pel(R) Coating. The device, as modified, will be marketed under the trade name USCI(R) ProCross(TM) SP Over-the-Wire Balloon Dilatation Catheters with Hydro/Pel(R) Coating and is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.

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510(k) clearances by this applicant

RecordFirmDate
Euphora Rapid Exchange (RX) Balloon Dilatation Catheter (K261759)Medtronic Ireland2026-07-27
Sprinter Legend Rapid Exchange Balloon Dilatation Catheter (K251970)Medtronic, Ireland2026-01-17
Telescope Guide Extension Catheter (K252390)Medtronic, Ireland2025-10-29
Liberant Thrombectomy System (K250787)Medtronic, Ireland2025-06-11
ATTAIN COMMAND+SUREVALVE LEFT HEART DELIVERY SYSTEM ATTAIN COMMAND GUIDE CATHETERS FOR LEFT HEART DELIVERY,ATTAIN SELECT (K123153)Medtronic, Ireland2013-04-09
SPRINTER LEGEND 1.25MM RX AND SPRINTER LEGEND 1.25MM OTW BALLOON (K103095)Medtronic, Ireland2010-10-22
ATTAIN 6227DEF DEFLECTABLE CATHETER DELIVERY SYSTEM (K061480)Medtronic, Ireland2006-08-21
ATTAIN SELECT II 6248DEL DELIVERY CATHETER SYSTEM (K053431)Medtronic, Ireland2006-03-16