PMA P010002S001

Device: INDERMIL TISSUE ADHESIVE
Applicant: Covidien Lp, Formerly Registered AS United States
PMA number: P010002
Supplement: S001
Product code: MPN
Decision date: 2002-06-20
Classification: General, Plastic Surgery
Generic name: Tissue adhesive for the topical approximation of skin
Approval order statement: APPROVAL FOR LABELING CHANGES TO INCLUDE AN EXTENSION TO THE LABELED DEVICE SHELF-LIFE FROM 12 MONTHS TO 24 MONTHS AND A 4-WEEK AMBIENT STORAGE CLAIM.

Current openFDA PMA Record#

Device: INDERMIL TISSUE ADHESIVE
Applicant: Covidien Lp, Formerly Registered AS United States
PMA number: P010002
Supplement: S001
Product code: MPN
Generic name: Tissue adhesive for the topical approximation of skin
Decision date: 2002-06-20
Decision code: APPR
Date received: 2002-05-24
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR LABELING CHANGES TO INCLUDE AN EXTENSION TO THE LABELED DEVICE SHELF-LIFE FROM 12 MONTHS TO 24 MONTHS AND A 4-WEEK AMBIENT STORAGE CLAIM.