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PMA P020052S003

Device
RESPONSE CV CARDIOVERSION ELECTROPHYSIOLOGY CATHETER
Applicant
St Jude Medical
PMA number
P020052
Supplement
S003
Product code
MTE
Decision date
2007-09-21
Classification
Cardiovascular
Generic name
System, pacing, temporary, acute, internal atrial defibrillation
Approval order statement
IMPLEMENTATION OF NEWLY QUALIFIED ELECTRODE RING SWAGING EQUIPMENT AND SWAGING DIES, FOR SWAGING ELECTRODE RINGS ONTO CATHETER SHAFT, AND PERFORMANCE OF PREVENTIVE CLEANING FOR SWAGING DIES.

Current openFDA PMA Record#

Device
RESPONSE CV CARDIOVERSION ELECTROPHYSIOLOGY CATHETER
Applicant
St Jude Medical
PMA number
P020052
Supplement
S003
Product code
MTE
Generic name
System, pacing, temporary, acute, internal atrial defibrillation
Decision date
2007-09-21
Decision code
OK30
Date received
2007-08-24
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
IMPLEMENTATION OF NEWLY QUALIFIED ELECTRODE RING SWAGING EQUIPMENT AND SWAGING DIES, FOR SWAGING ELECTRODE RINGS ONTO CATHETER SHAFT, AND PERFORMANCE OF PREVENTIVE CLEANING FOR SWAGING DIES.