PMA P970035

Device
S-SERIES CORONARY STENT SYSTEMS
Applicant
Medtronic, Ireland
PMA number
P970035
Supplement
S023
Product code
MAF
Decision date
2007-08-30
Generic name
STENT, CORONARY
Approval order statement
REDUCTION IN THE NUMBER OF SAMPLES WHICH ARE TAKEN TO MONITOR PARTICULATE LEVELS IN NITROGEN GAS AND COMPRESSED AIR.

Current openFDA PMA Record

Device
S-SERIES CORONARY STENT SYSTEMS
Applicant
Medtronic, Ireland
PMA number
P970035
Supplement
S047
Product code
MAF
Generic name
STENT, CORONARY
Decision date
2007-08-30
Decision code
OK30
Date received
2007-08-01
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
REDUCTION IN THE NUMBER OF SAMPLES WHICH ARE TAKEN TO MONITOR PARTICULATE LEVELS IN NITROGEN GAS AND COMPRESSED AIR.

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