PMA P910023S319
- Device
- CURRENT+, FORTIFY, FORTIFY ASSURA, ELLIPSE FAMILIES OF ICD DEVICES
- Applicant
- ABBOTT MEDICAL
- PMA number
- P910023
- Supplement
- S319
- Product code
- NVZ
- Decision date
- 2013-06-11
- Classification
- Pulse Generator, Permanent, Implantable
- Generic name
- Pulse generator, permanent, implantable
- Approval order statement
- ADDITION OF A BARRIER LAYER FOR THE FINAL FINISH OF HYBRID SUBSTRATES.
Current openFDA PMA Record#
- Device
- CURRENT+, FORTIFY, FORTIFY ASSURA, ELLIPSE FAMILIES OF ICD DEVICES
- Applicant
- ABBOTT MEDICAL
- PMA number
- P910023
- Supplement
- S319
- Product code
- NVZ
- Generic name
- Pulse generator, permanent, implantable
- Decision date
- 2013-06-11
- Decision code
- OK30
- Date received
- 2013-05-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADDITION OF A BARRIER LAYER FOR THE FINAL FINISH OF HYBRID SUBSTRATES.