PMA P130024S003
- Device
- LUTONIX DRUG COATED BALLOON
- Applicant
- Lutonix
- PMA number
- P130024
- Supplement
- S003
- Product code
- ONU
- Decision date
- 2015-11-23
- Classification
- Drug-eluting Peripheral Transluminal Angioplasty Catheter
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Approval order statement
- APPROVAL TO CHANGE THE PARTICULATE SPECIFICATION FOR THE DEVICE AT LOT RELEASE AND STABILITY TESTING.
Current openFDA PMA Record#
- Device
- LUTONIX DRUG COATED BALLOON
- Applicant
- Lutonix
- PMA number
- P130024
- Supplement
- S003
- Product code
- ONU
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Decision date
- 2015-11-23
- Decision code
- APPR
- Date received
- 2015-02-25
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL TO CHANGE THE PARTICULATE SPECIFICATION FOR THE DEVICE AT LOT RELEASE AND STABILITY TESTING.