PMA P880086S226
- Device
- IDENTITY, INTEGRITY, AFFINITY, VERITY, VICTORY, ZEPHYR, SUSTAIN, ACCENT
- Applicant
- ABBOTT MEDICAL
- PMA number
- P880086
- Supplement
- S226
- Product code
- NVZ
- Decision date
- 2012-10-10
- Classification
- Pulse Generator, Permanent, Implantable
- Generic name
- Pulse generator, permanent, implantable
- Approval order statement
- CHANGES TO THE BIOBURDEN ACTION LEVEL AND BIOBURDEN ACTION LIMIT.
Current openFDA PMA Record#
- Device
- IDENTITY, INTEGRITY, AFFINITY, VERITY, VICTORY, ZEPHYR, SUSTAIN, ACCENT
- Applicant
- ABBOTT MEDICAL
- PMA number
- P880086
- Supplement
- S226
- Product code
- NVZ
- Generic name
- Pulse generator, permanent, implantable
- Decision date
- 2012-10-10
- Decision code
- OK30
- Date received
- 2012-09-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGES TO THE BIOBURDEN ACTION LEVEL AND BIOBURDEN ACTION LIMIT.