PMA P960043S111

Device
Perclose ProGlide Suture-Mediated Closure System
Applicant
Abbott Vascular, Inc.
PMA number
P960043
Supplement
S111
Product code
MGB
Decision date
2021-02-26
Generic name
Device, hemostasis, vascular
Approval order statement
Implementation of a post-cure process step for a component of the Perclose Suture Trimmer accessory.

Current openFDA PMA Record#

Device
Perclose ProGlide Suture-Mediated Closure System
Applicant
Abbott Vascular, Inc.
PMA number
P960043
Supplement
S111
Product code
MGB
Generic name
Device, hemostasis, vascular
Decision date
2021-02-26
Decision code
OK30
Date received
2021-01-29
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Implementation of a post-cure process step for a component of the Perclose Suture Trimmer accessory.