PMA P150024S003

Device
AspireAssist
Applicant
Aspire Bariatrics, Inc.
PMA number
P150024
Supplement
S003
Product code
OYF
Decision date
2016-09-13
Generic name
Aspiration therapy system
Approval order statement
Approval for the addition of a Skin-Port manufacturing in-process leak test.

Current openFDA PMA Record#

Device
AspireAssist
Applicant
Aspire Bariatrics, Inc.
PMA number
P150024
Supplement
S003
Product code
OYF
Generic name
Aspiration therapy system
Decision date
2016-09-13
Decision code
APPR
Date received
2016-08-15
Supplement type
Special (Immediate Track)
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Approval for the addition of a Skin-Port manufacturing in-process leak test.