PMA P030054S162
- Device
- CURRENT + DEVICES & CURRENT ACCEL DEVICES
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S162
- Product code
- NIK
- Decision date
- 2010-09-09
- 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 OF THE POST-APPROVAL STUDY PROTOCOL.
Current openFDA PMA Record#
- Device
- CURRENT + DEVICES & CURRENT ACCEL DEVICES
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S162
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2010-09-09
- Decision code
- APPR
- Date received
- 2010-07-13
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Approval order statement
- APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.