PMA P010002S002

Device: INDERMIL TISSUE ADHESIVE
Applicant: Covidien Lp, Formerly Registered AS United States
PMA number: P010002
Supplement: S002
Product code: MPN
Decision date: 2002-06-28
Classification: General, Plastic Surgery
Generic name: Tissue adhesive for the topical approximation of skin
Approval order statement: PACKAGING CHANGE FROM A 5 AND 20 UNIT DOSE CONFIGURATION TO A NEW 12 AND 24 UNIT DOSE CONFIGURATION. THE PACKAGING CHANGES WILL MAKE GREATER USE OF THE SPACE WITHIN THE PACKAGING AND ALLOW MORE UNITS TO BE SHIPPED IN THE SAME OR SLIGHTLY INCREASED VOLUME PACKAGING.

Current openFDA PMA Record#

Device: INDERMIL TISSUE ADHESIVE
Applicant: Covidien Lp, Formerly Registered AS United States
PMA number: P010002
Supplement: S002
Product code: MPN
Generic name: Tissue adhesive for the topical approximation of skin
Decision date: 2002-06-28
Decision code: OK30
Date received: 2002-05-29
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: PACKAGING CHANGE FROM A 5 AND 20 UNIT DOSE CONFIGURATION TO A NEW 12 AND 24 UNIT DOSE CONFIGURATION. THE PACKAGING CHANGES WILL MAKE GREATER USE OF THE SPACE WITHIN THE PACKAGING AND ALLOW MORE UNITS TO BE SHIPPED IN THE SAME OR SLIGHTLY INCREASED VOLUME PACKAGING.