PMA P860019S133
- Device
- SCIMED BANDIT AND RANGER PTCA CATHETERS
- Applicant
- Scimed Life Systems, Inc.
- PMA number
- P860019
- Supplement
- S133
- Product code
- LOX
- Decision date
- 1997-10-31
- Classification
- Catheters, Transluminal Coronary Angioplasty, Percutaneous
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Approval order statement
- Additional manufacturing site located at Boston Scientific Ireland and the sterilization facility at Isotron Ireland, Ltd.
Current openFDA PMA Record#
- Device
- SCIMED BANDIT AND RANGER PTCA CATHETERS
- Applicant
- Scimed Life Systems, Inc.
- PMA number
- P860019
- Supplement
- S133
- Product code
- LOX
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Decision date
- 1997-10-31
- Decision code
- APPR
- Date received
- 1997-10-14
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Additional manufacturing site located at Boston Scientific Ireland and the sterilization facility at Isotron Ireland, Ltd.