PMA P860019S194
- Device
- REMEDY CORONARY BALLOON DILATATION INFUSION CATHETER
- Applicant
- Scimed Life Systems, Inc.
- PMA number
- P860019
- Supplement
- S194
- Product code
- LOX
- Decision date
- 2003-04-01
- Classification
- Catheters, Transluminal Coronary Angioplasty, Percutaneous
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Approval order statement
- APPROVAL TO MANUFACTURE THE REMEDY CATHETER BALLOON COMPONENT AT BOSTON SCIENTIFIC IRELAND LIMITED, GALWAY, IRELAND.
Current openFDA PMA Record#
- Device
- REMEDY CORONARY BALLOON DILATATION INFUSION CATHETER
- Applicant
- Scimed Life Systems, Inc.
- PMA number
- P860019
- Supplement
- S194
- Product code
- LOX
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Decision date
- 2003-04-01
- Decision code
- APPR
- Date received
- 2002-12-24
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL TO MANUFACTURE THE REMEDY CATHETER BALLOON COMPONENT AT BOSTON SCIENTIFIC IRELAND LIMITED, GALWAY, IRELAND.