OVATIO VR & DR ICDS
FDA premarket approval P980049/S031 · decided 2008-03-20
Approval details
- PMA number
- P980049
- Supplement
- S031
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- OVATIO VR & DR ICDS
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2008-02-15
- Decision date
- 2008-03-20
- Days to decision
- 34 days
- Decision code
- OK30
- Product code
- MRM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- ADDING A SECOND SUPPLIER FOR HYBRID MODULES USED IN THE MANUFACTURE OF THE DEVICE.
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