PMA P910031S026
- Device
- NC MERLIN PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER
- Applicant
- Abbott Vascular Devices
- PMA number
- P910031
- Supplement
- S026
- Product code
- LOX
- Decision date
- 2009-08-26
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Approval order statement
- CHANGE IN THE EQUIPMENT USED TO MANUFACTURE THE BALLOONS.
Current openFDA PMA Record#
- Device
- NC MERLIN PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER
- Applicant
- Abbott Vascular Devices
- PMA number
- P910031
- Supplement
- S026
- Product code
- LOX
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Decision date
- 2009-08-26
- Decision code
- OK30
- Date received
- 2009-07-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE IN THE EQUIPMENT USED TO MANUFACTURE THE BALLOONS.