PMA P890001S020
- Device
- LEOCOR SABLE(TM) PTCA CATHETER
- Applicant
- Leocor, Inc.
- PMA number
- P890001
- Supplement
- S020
- Product code
- LOX
- Decision date
- 1997-01-16
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Approval order statement
- MODIFIED DEVICE PACKAGING FOR ALL LEOCOR'S CURRENTLY MARKETED PTCA CATHETERS.
Current openFDA PMA Record#
- Device
- LEOCOR SABLE(TM) PTCA CATHETER
- Applicant
- Leocor, Inc.
- PMA number
- P890001
- Supplement
- S020
- Product code
- LOX
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Decision date
- 1997-01-16
- Decision code
- APPR
- Date received
- 1996-11-29
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- MODIFIED DEVICE PACKAGING FOR ALL LEOCOR'S CURRENTLY MARKETED PTCA CATHETERS.