PMA P790017S107
- Device
- SPRINTER LEGEND RX BALLOON DILATATION CATHETER
- Applicant
- Medtronic, Ireland
- PMA number
- P790017
- Supplement
- S107
- Product code
- LOX
- Decision date
- 2010-04-21
- Classification
- Catheters, Transluminal Coronary Angioplasty, Percutaneous
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Approval order statement
- ADDITIONAL VENDOR FOR A COMPONENT OF THE DEVICE.
Current openFDA PMA Record#
- Device
- SPRINTER LEGEND RX BALLOON DILATATION CATHETER
- Applicant
- Medtronic, Ireland
- PMA number
- P790017
- Supplement
- S107
- Product code
- LOX
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Decision date
- 2010-04-21
- Decision code
- OK30
- Date received
- 2010-03-22
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADDITIONAL VENDOR FOR A COMPONENT OF THE DEVICE.