|
Device | ARISTA AH, ARISTA AH FLEXITIP/FLEXITIP XL/ FLEXITIP XL-R |
Generic Name | Agent, absorbable hemostatic, non-collagen based |
Regulation Number | 878.4490 |
Applicant | Davol, Inc. 100 Crossings Boulevard Warwick, RI 02886 |
PMA Number | P050038 |
Supplement Number | S024 |
Date Received | 05/27/2015 |
Decision Date | 06/24/2015 |
Product Code |
LMG |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement QUALIFICATION OF AN ADDITIONAL POUCH SEALER. |