CURRENT/PROMOTE, CURRENT ACCEL/PROMOTE ACCELL & CURRENT+/PROMOTE+FAMILIES ICDS/CRT-DS
FDA premarket approval P030054/S175 · decided 2010-12-15
Approval details
- PMA number
- P030054
- Supplement
- S175
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CURRENT/PROMOTE, CURRENT ACCEL/PROMOTE ACCELL & CURRENT+/PROMOTE+FAMILIES ICDS/CRT-DS
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- ABBOTT MEDICAL
- Date received
- 2010-11-15
- Decision date
- 2010-12-15
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- ALTERNATE ATTACHMENT PROCESS FOR THE ITMS AND L2 COIL TO THE UNITY HYBRID ASSEMBLY.
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