- Device
- ULTRA2 CUTTING BALLOON MONORAIL(MR)
- Applicant
- Boston Scientific Corp
- PMA number
- P950020
- Supplement
- S012
- Product code
- LIT
- Generic name
- Catheter, angioplasty, peripheral, transluminal
- Decision date
- 2005-03-16
- Decision code
- APPR
- Date received
- 2004-11-08
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR MANUFACTURING SITES LOCATED AT INTERVENTIONAL TECHNOLOGIES EUROPE, LTD., DONEGAL, IRELAND AND EBIS IOTRON, LTD., OXON, GREAT BRITAIN.