PMA P910023S050
- Device
- CADENCE FAMILY OF IMPLANTABLE CARDIOVERTER DEFIBRILLATORS AND THE TVL LEAD SYSTEM
- Applicant
- ABBOTT MEDICAL
- PMA number
- P910023
- Supplement
- S050
- Product code
- LWS
- Decision date
- 2001-01-18
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- USE OF AN ALTERNATE STERILIZATION CHAMBER FOR THE ICDS AND TACHYCARDIA LEADS AND IS ALSO REQUESTING APPROVAL FOR USE OF PARAMETRIC RELEASE AS AN ALTERNATE TO THE CURRENT USE OF BIOLOGICAL INDICATORS IN THE RELEASE OF STERILIZED PRODUCTS.
Current openFDA PMA Record#
- Device
- CADENCE FAMILY OF IMPLANTABLE CARDIOVERTER DEFIBRILLATORS AND THE TVL LEAD SYSTEM
- Applicant
- ABBOTT MEDICAL
- PMA number
- P910023
- Supplement
- S050
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2001-01-18
- Decision code
- OK30
- Date received
- 2000-12-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- USE OF AN ALTERNATE STERILIZATION CHAMBER FOR THE ICDS AND TACHYCARDIA LEADS AND IS ALSO REQUESTING APPROVAL FOR USE OF PARAMETRIC RELEASE AS AN ALTERNATE TO THE CURRENT USE OF BIOLOGICAL INDICATORS IN THE RELEASE OF STERILIZED PRODUCTS.