PMA P020045S038
- Device
- FREEZOR/FREEZOR XTRA/FREEZOR MAX CRYOABLATION CATHETERS AND THE CRYOCONSOLE
- Applicant
- Medtronic Cryocath, LP
- PMA number
- P020045
- Supplement
- S038
- Product code
- LPB
- Decision date
- 2011-04-29
- Classification
- Cardiac Ablation Percutaneous Catheter
- Generic name
- Cardiac ablation percutaneous catheter
- Approval order statement
- TRANSFER THE GAS FILLING AND TESTING OPERATIONS FOR THE COMPRESSOR SUBASSEMBLY TO THE SUPPLIER.
Current openFDA PMA Record#
- Device
- FREEZOR/FREEZOR XTRA/FREEZOR MAX CRYOABLATION CATHETERS AND THE CRYOCONSOLE
- Applicant
- Medtronic Cryocath, LP
- PMA number
- P020045
- Supplement
- S038
- Product code
- LPB
- Generic name
- Cardiac ablation percutaneous catheter
- Decision date
- 2011-04-29
- Decision code
- OK30
- Date received
- 2011-03-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- TRANSFER THE GAS FILLING AND TESTING OPERATIONS FOR THE COMPRESSOR SUBASSEMBLY TO THE SUPPLIER.