|
Device | INDERMIL TISSUE ADHESIVE |
Generic Name | Tissue adhesive for the topical approximation of skin |
Regulation Number | 878.4010 |
Applicant | COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES 150 GLOVER AVE. NORWALK, CT 06856 |
PMA Number | P010002 |
Supplement Number | S001 |
Date Received | 05/24/2002 |
Decision Date | 06/20/2002 |
Reclassified Date
|
05/05/2008 |
Product Code |
MPN |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
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. |