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SPRINTER OVER THE WIRE (OTW) & SPRINTER MULTI-EXCHANGE (MX2) BALLOON DILATATION CATHETER

FDA premarket approval P790017/S088 · decided 2007-08-29

Approval details

PMA number
P790017
Supplement
S088
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name
SPRINTER OVER THE WIRE (OTW) & SPRINTER MULTI-EXCHANGE (MX2) BALLOON DILATATION CATHETER
Generic name
Catheters, transluminal coronary angioplasty, percutaneous
Applicant
Medtronic, Ireland
Date received
2007-07-30
Decision date
2007-08-29
Days to decision
30 days
Decision code
OK30
Product code
LOX
Advisory committee
Cardiovascular
Expedited review
No
Location
Galway
Statement
ADDING ISOTRON IRELAND, ONE OF MEDTRONIC?S APPROVED CONTRACT ETHYLENE OXIDE (ETO) STERILIZATION FACILITIES, TO RECEIVE, STORE, AND PREPARE BIOLOGICAL INDICATORS FOR ROUTINE STERILIZATION CYCLES AND TO COMPLETE VIABILITY TESTING.

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