PMA P860019S138
- Device
- SCIMED REBEL PTCA CATHETER
- Applicant
- Scimed Life Systems, Inc.
- PMA number
- P860019
- Supplement
- S138
- Product code
- LOX
- Decision date
- 1998-04-06
- Classification
- Catheters, Transluminal Coronary Angioplasty, Percutaneous
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Approval order statement
- Approval for additional balloon lengths of 16 mm and 18 mm with balloon sizes of 2.5 mm up to 4.0 mm in 1/4 mm increments for the SCIMED(R) NC Ranger(TM) PTCA Catheter.
Current openFDA PMA Record#
- Device
- SCIMED REBEL PTCA CATHETER
- Applicant
- Scimed Life Systems, Inc.
- PMA number
- P860019
- Supplement
- S138
- Product code
- LOX
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Decision date
- 1998-04-06
- Decision code
- APPR
- Date received
- 1998-02-25
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for additional balloon lengths of 16 mm and 18 mm with balloon sizes of 2.5 mm up to 4.0 mm in 1/4 mm increments for the SCIMED(R) NC Ranger(TM) PTCA Catheter.