PMA P790017S104
- Device
- GRUNTZIG DILACA BALLOON DILATATION CATHETERS
- Applicant
- Medtronic, Ireland
- PMA number
- P790017
- Supplement
- S104
- Product code
- LOX
- Decision date
- 2010-06-04
- Classification
- Catheters, Transluminal Coronary Angioplasty, Percutaneous
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Approval order statement
- APPROVAL FOR A CHANGE TO THE BALLOON SUBASSEMBLY MANUFACTURING PROCESS.
Current openFDA PMA Record#
- Device
- GRUNTZIG DILACA BALLOON DILATATION CATHETERS
- Applicant
- Medtronic, Ireland
- PMA number
- P790017
- Supplement
- S104
- Product code
- LOX
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Decision date
- 2010-06-04
- Decision code
- APPR
- Date received
- 2009-12-24
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A CHANGE TO THE BALLOON SUBASSEMBLY MANUFACTURING PROCESS.