PMA P010002S003

Device
INDERMIL TISSUE ADHESIVE
Applicant
Covidien Lp, Formerly Registered AS United States
PMA number
P010002
Supplement
S003
Product code
MPN
Decision date
2003-01-31
Classification
General, Plastic Surgery
Generic name
Tissue adhesive for the topical approximation of skin
Approval order statement
APPROVAL FOR THE ADDITION OF A PATIENT INSTRUCTION SHEET TO THE APPROVED LABELING.

Current openFDA PMA Record#

Device
INDERMIL TISSUE ADHESIVE
Applicant
Covidien Lp, Formerly Registered AS United States
PMA number
P010002
Supplement
S003
Product code
MPN
Generic name
Tissue adhesive for the topical approximation of skin
Decision date
2003-01-31
Decision code
APPR
Date received
2002-12-13
Supplement type
Special (Immediate Track)
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
APPROVAL FOR THE ADDITION OF A PATIENT INSTRUCTION SHEET TO THE APPROVED LABELING.