QUICKSITE, QUICKFLEX, AND QUICKFLEX LEADS
FDA premarket approval P030054/S150 · decided 2015-08-13
Approval details
- PMA number
- P030054
- Supplement
- S150
- Supplement type
- Normal 180 Day Track
- Trade name
- QUICKSITE, QUICKFLEX, AND QUICKFLEX LEADS
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- ABBOTT MEDICAL
- Date received
- 2010-05-20
- Decision date
- 2015-08-13
- Days to decision
- 1911 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- APPROVAL FOR MCRD AND STEROID COATING TEST METHODOLOGIES, SPECIFICATIONS, STABILITY PROTOCOLS AND OTHER MANUFACTURING PROCESSES TO MEET THE REQUIREMENTS IN THE AGREED UPON STEROID COMMITMENT LETTER.
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