PMA P880086S199
- Device
- FAMILY OF CRT-PS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P880086
- Supplement
- S199
- Product code
- NVZ
- Decision date
- 2011-05-10
- Classification
- Pulse Generator, Permanent, Implantable
- Generic name
- Pulse generator, permanent, implantable
- Approval order statement
- APPROVAL FOR TIGHTER SCREENING LIMITS AND THE INCLUSION OF A REFLOW THERMAL CONDITIONING DURING THE MANUFACTURE OF TANTALUM CAPACITOR COMPONENTS.
Current openFDA PMA Record#
- Device
- FAMILY OF CRT-PS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P880086
- Supplement
- S199
- Product code
- NVZ
- Generic name
- Pulse generator, permanent, implantable
- Decision date
- 2011-05-10
- Decision code
- APPR
- Date received
- 2011-03-22
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR TIGHTER SCREENING LIMITS AND THE INCLUSION OF A REFLOW THERMAL CONDITIONING DURING THE MANUFACTURE OF TANTALUM CAPACITOR COMPONENTS.