PMA P020045S102
- Device
- 7F Freezor Cardiac Cryoablation Catheter, 7F Freezor Xtra Cardiac Cryoablation Catheter
- Applicant
- Medtronic Cryocath, LP
- PMA number
- P020045
- Supplement
- S102
- Product code
- LPB
- Decision date
- 2023-01-19
- Generic name
- Cardiac ablation percutaneous catheter
- Approval order statement
- Supplier, mold, and drawing changes for the Freezor 7Fr and 9Fr Y-Blocks.
Current openFDA PMA Record#
- Device
- 7F Freezor Cardiac Cryoablation Catheter, 7F Freezor Xtra Cardiac Cryoablation Catheter
- Applicant
- Medtronic Cryocath, LP
- PMA number
- P020045
- Supplement
- S102
- Product code
- LPB
- Generic name
- Cardiac ablation percutaneous catheter
- Decision date
- 2023-01-19
- Decision code
- OK30
- Date received
- 2022-12-22
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Supplier, mold, and drawing changes for the Freezor 7Fr and 9Fr Y-Blocks.