| Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling. |
| |
| Device | INDERMIL(TM) 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 |
|---|
| Date Received | 02/01/2001 |
|---|
| Decision Date | 05/22/2002 |
|---|
|
Reclassified Date
|
05/05/2008 |
|---|
| Product Code |
MPN |
| Docket Number | 03M-0040 |
|---|
| Notice Date | 02/05/2003 |
|---|
| Advisory Committee |
General & Plastic Surgery |
|---|
| Expedited Review Granted? | No |
|---|
| Combination Product | No |
|---|
Approval Order Statement
APPROVAL FOR THE INDERMIL TISSUE ADHESIVE. THE DEVICE IS INDICATED FOR THE CLOSURE OF TOPICAL SKIN INCISIONS INCLUDING LAPAROSCOPIC INCISIONS, AND TRAUMA-INDUCED LACERATIONS IN AREAS OF LOW SKIN TENSION THAT ARE SIMPLE, THOROUGHLY-CLEANSED, AND HAVE EASILY APPROXIMATED SKIN EDGES. INDERMIL MAY BE USED IN CONJUNCTION WITH, BUT NOT IN PLACE OF, DEEP DERMAL STITCHES. |
| Approval Order | Approval Order |
|---|
| Summary | Summary of Safety and Effectiveness |
|---|
| Labeling | Labeling
|
|---|
| Supplements: |
S001 S002 S003 S004 |
|
|
