PMA P880086S181
- Device
- AFFINITY/IDENTITY/VERITY/INTERGRITY/VICTORY & ZEPHYR PACEMAKERS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P880086
- Supplement
- S181
- Product code
- NVZ
- Decision date
- 2010-02-03
- Classification
- Pulse Generator, Permanent, Implantable
- Generic name
- Pulse generator, permanent, implantable
- Approval order statement
- APPROVAL FOR THE ADDITION OF AN ALTERNATE STERILIZATION CYCLE.
Current openFDA PMA Record#
- Device
- AFFINITY/IDENTITY/VERITY/INTERGRITY/VICTORY & ZEPHYR PACEMAKERS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P880086
- Supplement
- S181
- Product code
- NVZ
- Generic name
- Pulse generator, permanent, implantable
- Decision date
- 2010-02-03
- Decision code
- APPR
- Date received
- 2009-10-02
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR THE ADDITION OF AN ALTERNATE STERILIZATION CYCLE.