PMA P000032S016
- Device
- HER OPTION CRYOABLATION THERAPY SYSTEM
- Applicant
- CooperSurgical, Inc.
- PMA number
- P000032
- Supplement
- S016
- Product code
- MNB
- Decision date
- 2006-02-02
- Generic name
- Device, thermal ablation, endometrial
- Approval order statement
- USE OF AN ALTERNATE RESISTOR SUPPLIER AND A CHANGE IN THE RESISTOR'S ASSEMBLY PROCESS.
Current openFDA PMA Record#
- Device
- HER OPTION CRYOABLATION THERAPY SYSTEM
- Applicant
- CooperSurgical, Inc.
- PMA number
- P000032
- Supplement
- S016
- Product code
- MNB
- Generic name
- Device, thermal ablation, endometrial
- Decision date
- 2006-02-02
- Decision code
- OK30
- Date received
- 2006-01-11
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- USE OF AN ALTERNATE RESISTOR SUPPLIER AND A CHANGE IN THE RESISTOR'S ASSEMBLY PROCESS.