PMA P910023S159
- Device
- CADENCE ICDS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P910023
- Supplement
- S159
- Product code
- NVZ
- Decision date
- 2008-05-16
- Classification
- Pulse Generator, Permanent, Implantable
- Generic name
- Pulse generator, permanent, implantable
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT STERI-TECH, INC., SALINAS, PUERTO RICO FOR ETHYLENE OXIDE STERILIZATION OF THE PACEMAKERS, ICDS AND LEADS.
Current openFDA PMA Record#
- Device
- CADENCE ICDS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P910023
- Supplement
- S159
- Product code
- NVZ
- Generic name
- Pulse generator, permanent, implantable
- Decision date
- 2008-05-16
- Decision code
- APPR
- Date received
- 2007-10-19
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT STERI-TECH, INC., SALINAS, PUERTO RICO FOR ETHYLENE OXIDE STERILIZATION OF THE PACEMAKERS, ICDS AND LEADS.