OVATIO VR 6250 & DR 6550 ICDS
FDA premarket approval P980049/S029 · decided 2008-12-05
Approval details
- PMA number
- P980049
- Supplement
- S029
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- OVATIO VR 6250 & DR 6550 ICDS
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2008-02-11
- Decision date
- 2008-12-05
- Days to decision
- 298 days
- Decision code
- APPR
- Product code
- MRM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- APPROVAL FOR A CHANGE IN THE LOT ACCEPTANCE LIFE TEST.
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