PMA P030054S117
- Device
- EPIC HF/ATLAS+ HF FAMILY OF CRT-DS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S117
- Product code
- NIK
- Decision date
- 2009-04-08
- Classification
- Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (crt-d)
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Approval order statement
- APPROVAL FOR CURRENT/CURRENT+ AND PROMOTE/PROMOTE+ DEVICES INCLUDING CURRENT- DR CD2211-36Q, CURRENT+ VR CD1211-36Q, PROMOTE + CD3211-36Q, CURRENT VR CD1207-36Q, CURRENT DR 2207-36Q, AND PROMOTE CD3207-36Q. ADDITIONALLY, YOUREQUESTED APPROVAL TO INCLUDE THE DEVICES WITHIN AN ONGOING POST APPROVAL STUDY, PENDING FINAL APPROVAL BY THE OFFICE OF SURVEILLANCE AND BIOMETRICS. THAT POST-APPROVAL STUDY IS BEING CONDUCTED AS A CONDITION OF APPROVAL FOR P950022/S042, P030054/S067, AND P910023/S154.
Current openFDA PMA Record#
- Device
- EPIC HF/ATLAS+ HF FAMILY OF CRT-DS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S117
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2009-04-08
- Decision code
- APPR
- Date received
- 2009-02-10
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR CURRENT/CURRENT+ AND PROMOTE/PROMOTE+ DEVICES INCLUDING CURRENT- DR CD2211-36Q, CURRENT+ VR CD1211-36Q, PROMOTE + CD3211-36Q, CURRENT VR CD1207-36Q, CURRENT DR 2207-36Q, AND PROMOTE CD3207-36Q. ADDITIONALLY, YOUREQUESTED APPROVAL TO INCLUDE THE DEVICES WITHIN AN ONGOING POST APPROVAL STUDY, PENDING FINAL APPROVAL BY THE OFFICE OF SURVEILLANCE AND BIOMETRICS. THAT POST-APPROVAL STUDY IS BEING CONDUCTED AS A CONDITION OF APPROVAL FOR P950022/S042, P030054/S067, AND P910023/S154.