PMA P860019S125
- Device
- SCIMED(R) RANGER(TM) PERCUTANEOUS CORONARY ANGIOPLASTY (PTCA) CATHETER
- Applicant
- Scimed Life Systems, Inc.
- PMA number
- P860019
- Supplement
- S125
- Product code
- LOX
- Decision date
- 1997-08-12
- Classification
- Catheters, Transluminal Coronary Angioplasty, Percutaneous
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Approval order statement
- APPROVAL FOR ADDITIONAL BALLOON SIZES (2.75 MM, 3.25 MM, AND 3.75 MM) FOR THE SCIMED(R) 15 MM AND 20 MM QUANTUM RANGER(TM) PTCA CATHETER.
Current openFDA PMA Record#
- Device
- SCIMED(R) RANGER(TM) PERCUTANEOUS CORONARY ANGIOPLASTY (PTCA) CATHETER
- Applicant
- Scimed Life Systems, Inc.
- PMA number
- P860019
- Supplement
- S125
- Product code
- LOX
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Decision date
- 1997-08-12
- Decision code
- APPR
- Date received
- 1997-06-30
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR ADDITIONAL BALLOON SIZES (2.75 MM, 3.25 MM, AND 3.75 MM) FOR THE SCIMED(R) 15 MM AND 20 MM QUANTUM RANGER(TM) PTCA CATHETER.