PMA P970052
- Device
- GUARDIAN CORONARY BALLOON DILATATION PTCA CATHETER
- Applicant
- Endologix, Inc.
- PMA number
- P970052
- Supplement
- S002
- Product code
- LOX
- Decision date
- 1998-05-19
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Approval order statement
- Approval for modifications to the Guardian(TM) Balloon Coronary Dilatation Catheter.
Current openFDA PMA Record#
- Device
- GUARDIAN CORONARY BALLOON DILATATION PTCA CATHETER
- Applicant
- Endologix, Inc.
- PMA number
- P970052
- Supplement
- S002
- Product code
- LOX
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Decision date
- 1998-05-19
- Decision code
- APPR
- Date received
- 1997-11-19
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for modifications to the Guardian(TM) Balloon Coronary Dilatation Catheter.