| Trade Name | ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM |
| Generic Name | |
| Applicant | ABBOTT VASCULAR INC. |
| PMA Number | P110028 |
| Recent Supplement Number | S007 |
| Contact | 3200 LAKESIDE DRIVE SANTA CLARA, CA, 95054 |
| Date Received | Jan 14, 2013 |
| Decision Date | Feb 12, 2013 |
| Product Code | NIO |
| Advisory Committee | CV |
| Supplement Type | 30-DAY NOTICE |
| Supplement Reason | PROCESS CHANGE: MANUFACTURING |
| Expedited Review Granted? | N |
| Order Approval Statement | ALIGN CLEAN ROOM ACTION LIMITS WITH A NEW STANDARD. |
| source | fda.gov |
| # | Decision Date | Reason/Type | Change |
|---|---|---|---|
| S006 | Jan 24, 2013 | PROCESS CHANGE - OTHER/30-DAY NOTICE | MANUFACTURING TRANSFER FOR THE DELIVERY SYSTEMS OF THE DEVICES WITHIN THE SAME SITE. |
| S005 | Nov 14, 2012 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | MODIFY THE STENT SUBASSEMBLY EXPANSION PROCESS. |
| S004 | Jul 11, 2012 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | CHANGE TO SAMPLE SIZE FOR PYROGEN TESTING. |
| S003 | Jun 21, 2012 | /30-DAY NOTICE | REDUCE THE NUMBER OF SAMPLES USED FROM EACH LOT DURING PYROGEN TESTING. |
| S002 | Jun 20, 2012 | PROCESS CHANGE: MANUFACTURING/30-DAY NOTICE | REDUCTION OF SAMPLING FREQUENCY FOR A MANUFACTURING PROCESS. |
| S001 | Jun 07, 2012 | /30-DAY NOTICE | CHANGES TO THE EXTRUDED TUBING PROCESS. |
| Feb 22, 2012 | Original Approval | APPROVAL FOR THE ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM. THE DEVICE IS INDICATED FOR IMPROVING LUMINAL DIAMETER IN PATIENTS WITH DE NOVO OR RESTENOTIC ATHEROSCLEROTIC LESIONS IN THE NATIVE COMMON ILIAC ARTERY AND NATIVE EXTERNAL ILIAC ARTERY WITH REFERENCE VESSEL DIAMETERS BETWEEN 4.3 MM AND 9.1 MM AND LESIONS LENGTHS UP TO 90 MM. |