PMA P890001S014
- Device
- LEOCOR PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY CATHETER AND LEOCOR PTCA CATHETER MODEL PICO-ST (COATED)
- Applicant
- Leocor, Inc.
- PMA number
- P890001
- Supplement
- S014
- Product code
- LOX
- Decision date
- 1996-06-13
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Approval order statement
- APPROVAL FOR REVISED LABELING
Current openFDA PMA Record#
- Device
- LEOCOR PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY CATHETER AND LEOCOR PTCA CATHETER MODEL PICO-ST (COATED)
- Applicant
- Leocor, Inc.
- PMA number
- P890001
- Supplement
- S014
- Product code
- LOX
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Decision date
- 1996-06-13
- Decision code
- APPR
- Date received
- 1995-06-21
- Supplement type
- THIRTY DAY TRACK
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR REVISED LABELING