- Device
- GUARDIAN CORONARY BALLOON DILATATION PTCA CATHETER
- Applicant
- Abbott Vascular Devices
- PMA number
- P910031
- Supplement
- S017
- Product code
- LOX
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Decision date
- 1997-11-10
- Decision code
- APPR
- Date received
- 1997-10-14
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for a change in the trade name from the LYNX(TM) to the Guardian(TM) Coronary Balloon Dilatation PTCA Catheter.