PROMOTE/PROMOTE + CRT-D
FDA premarket approval P030054/S120 · decided 2009-04-16
Approval details
- PMA number
- P030054
- Supplement
- S120
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- PROMOTE/PROMOTE + CRT-D
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- ABBOTT MEDICAL
- Date received
- 2009-03-23
- Decision date
- 2009-04-16
- Days to decision
- 24 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- APPROVAL TO EXTEND THE SHELF LIFE OF THE DEVICE.
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