PMA P880086S144
- Device
- AFFINITY PACEMAKERS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P880086
- Supplement
- S144
- Product code
- NVZ
- Decision date
- 2007-05-16
- Classification
- Pulse Generator, Permanent, Implantable
- Generic name
- Pulse generator, permanent, implantable
- Approval order statement
- USE OF SECOND SOURCE VENDORS FOR SEVERAL DISCRETE COMPONENTS ON THE DEVICE HYBRID.
Current openFDA PMA Record#
- Device
- AFFINITY PACEMAKERS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P880086
- Supplement
- S144
- Product code
- NVZ
- Generic name
- Pulse generator, permanent, implantable
- Decision date
- 2007-05-16
- Decision code
- OK30
- Date received
- 2007-04-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- USE OF SECOND SOURCE VENDORS FOR SEVERAL DISCRETE COMPONENTS ON THE DEVICE HYBRID.