SITUS OTW UW28D LEFT VENTRICULAR PACING LEAD
FDA premarket approval P060027/S007 · decided 2009-03-26
Approval details
- PMA number
- P060027
- Supplement
- S007
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SITUS OTW UW28D LEFT VENTRICULAR PACING LEAD
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2008-11-10
- Decision date
- 2009-03-26
- Days to decision
- 136 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- APPROVAL TO CHANGE THE LOCATION FOR MANUFACTURING THE STEROID COMPONENT OF THE DEVICE.
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