DEFENDER II MODEL 9201 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
FDA premarket approval P980049 · decided 1999-09-15
Approval details
- PMA number
- P980049
- Trade name
- DEFENDER II MODEL 9201 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 1998-12-18
- Decision date
- 1999-09-15
- Days to decision
- 271 days
- Decision code
- APPR
- Product code
- MRM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- This device is indicated for use in patients who are at risk of sudden death due to ventricular arrhythmias and have expierienced one of the following situations: 1) survival of at least one episode of cardiac arrest (manifested by loss of consciousness) due to a ventricular tachyarrhythmia; 2) recurrent poorly tolerated, sustained ventricular tachycardia (VT).
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