PMA P140010S016
- Device
- IN PACT ADMIRAL PACLITAXEL-ELUTING PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER
- Applicant
- Medtronic, Inc.
- PMA number
- P140010
- Supplement
- S016
- Product code
- ONU
- Decision date
- 2016-04-19
- Classification
- Drug-eluting Peripheral Transluminal Angioplasty Catheter
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Approval order statement
- Modifications to the annual stability protocol.
Current openFDA PMA Record#
- Device
- IN PACT ADMIRAL PACLITAXEL-ELUTING PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER
- Applicant
- Medtronic, Inc.
- PMA number
- P140010
- Supplement
- S016
- Product code
- ONU
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Decision date
- 2016-04-19
- Decision code
- OK30
- Date received
- 2016-03-22
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modifications to the annual stability protocol.