PMA P020045S090
- Device
- Freezor Cardiac Cryoablation System
- Applicant
- Medtronic Cryocath, LP
- PMA number
- P020045
- Supplement
- S090
- Product code
- LPB
- Decision date
- 2019-10-09
- Classification
- Cardiac Ablation Percutaneous Catheter
- Generic name
- Cardiac ablation percutaneous catheter
- Approval order statement
- Modification of an inspection test specific to check valve (CV6) in the CryoConsole.
Current openFDA PMA Record#
- Device
- Freezor Cardiac Cryoablation System
- Applicant
- Medtronic Cryocath, LP
- PMA number
- P020045
- Supplement
- S090
- Product code
- LPB
- Generic name
- Cardiac ablation percutaneous catheter
- Decision date
- 2019-10-09
- Decision code
- OK30
- Date received
- 2019-09-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modification of an inspection test specific to check valve (CV6) in the CryoConsole.