Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
|
Device | ABSOLUTE PRO VASCULAR STENT SYSTEMS |
Generic Name | STENT, ILIAC |
Applicant | ABBOTT VASCULAR INC. 3200 LAKESIDE DRIVE SANTA CLARA, CA 92054 |
PMA Number | P110028 |
Supplement Number | S014 |
Date Received | 01/14/2015 |
Decision Date | 02/06/2015 |
Product Code |
NIO |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement IMPLEMENT AN ALTERNATE DIGESTION SYSTEM USED TO PREPARE PURCHASED STAINLESS STEEL SAMPLES FOR CHEMICAL CHARACTERIZATION. |
|
|