OVATIO CRT
FDA premarket approval P060027/S013 · decided 2009-05-01
Approval details
- PMA number
- P060027
- Supplement
- S013
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- OVATIO CRT
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2009-03-31
- Decision date
- 2009-05-01
- Days to decision
- 31 days
- Decision code
- OK30
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- IMPROVEMENT IN MANUFACTURING BAL SEAL VERIFICATION.
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