PMA P150005S057

Device
MetriQ Irrigation Tubing Set
Applicant
Boston Scientific Corp
PMA number
P150005
Supplement
S057
Product code
OAD
Decision date
2020-10-09
Generic name
catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Approval order statement
Approval to modify the Loctite adhesive material used in the manufacture of the MetriQ Irrigation Tubing Set.

Current openFDA PMA Record#

Device
MetriQ Irrigation Tubing Set
Applicant
Boston Scientific Corp
PMA number
P150005
Supplement
S057
Product code
OAD
Generic name
catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Decision date
2020-10-09
Decision code
APPR
Date received
2020-09-28
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval to modify the Loctite adhesive material used in the manufacture of the MetriQ Irrigation Tubing Set.