PMA P880086S263
- Device
- VICTORY, ZEPHYR, ACCENT, ASSURITY, ASSURITY+, ENDURITY, IDENTITY ADX, VERITY ADX
- Applicant
- ABBOTT MEDICAL
- PMA number
- P880086
- Supplement
- S263
- Product code
- NVZ
- Decision date
- 2016-04-28
- Classification
- Pulse Generator, Permanent, Implantable
- Generic name
- Pulse generator, permanent, implantable
- Approval order statement
- Approval for the reassessment of microbiological levels for cleanrooms.
Current openFDA PMA Record#
- Device
- VICTORY, ZEPHYR, ACCENT, ASSURITY, ASSURITY+, ENDURITY, IDENTITY ADX, VERITY ADX
- Applicant
- ABBOTT MEDICAL
- PMA number
- P880086
- Supplement
- S263
- Product code
- NVZ
- Generic name
- Pulse generator, permanent, implantable
- Decision date
- 2016-04-28
- Decision code
- APPR
- Date received
- 2015-10-26
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for the reassessment of microbiological levels for cleanrooms.