PMA P860004S127

Device
PERSONAL THERAPY MANAGER (MYPTM)
Applicant
Medtronic, Inc.
PMA number
P860004
Supplement
S127
Product code
LKK
Decision date
2010-05-20
Classification
Pump, Infusion, Implanted, Programmable
Generic name
Pump, infusion, implanted, programmable
Approval order statement
ADDITION OF THE SUPPLEMENTAL AUTOMATED OPTICAL INSPECTION (AOI).

Current openFDA PMA Record#

Device
PERSONAL THERAPY MANAGER (MYPTM)
Applicant
Medtronic, Inc.
PMA number
P860004
Supplement
S127
Product code
LKK
Generic name
Pump, infusion, implanted, programmable
Decision date
2010-05-20
Decision code
OK30
Date received
2010-04-20
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
ADDITION OF THE SUPPLEMENTAL AUTOMATED OPTICAL INSPECTION (AOI).