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PMA P150005S065

Device
MetriQ Irrigation Tubing Set
Applicant
Boston Scientific Corp
PMA number
P150005
Supplement
S065
Product code
OAD
Decision date
2021-07-21
Generic name
catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Approval order statement
Change to the lubricant used in the polycarbonate base resign and to add an alternative dye technology for the 4-way stopcock component used in the MetriQ Irrigation Tubing Set.

Current openFDA PMA Record#

Device
MetriQ Irrigation Tubing Set
Applicant
Boston Scientific Corp
PMA number
P150005
Supplement
S065
Product code
OAD
Generic name
catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Decision date
2021-07-21
Decision code
OK30
Date received
2021-06-25
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Change to the lubricant used in the polycarbonate base resign and to add an alternative dye technology for the 4-way stopcock component used in the MetriQ Irrigation Tubing Set.