|
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 | S003 |
Date Received | 12/13/2002 |
Decision Date | 01/31/2003 |
Reclassified Date
|
05/05/2008 |
Product Code |
MPN |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE ADDITION OF A PATIENT INSTRUCTION SHEET TO THE APPROVED LABELING. |