PMA P880086S188
- Device
- AFFINITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P880086
- Supplement
- S188
- Product code
- NVZ
- Decision date
- 2010-06-18
- Classification
- Pulse Generator, Permanent, Implantable
- Generic name
- Pulse generator, permanent, implantable
- Approval order statement
- ALTERNATE METHOD OF BIOBURDEN TESTING.
Current openFDA PMA Record#
- Device
- AFFINITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P880086
- Supplement
- S188
- Product code
- NVZ
- Generic name
- Pulse generator, permanent, implantable
- Decision date
- 2010-06-18
- Decision code
- OK30
- Date received
- 2010-05-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ALTERNATE METHOD OF BIOBURDEN TESTING.