PHYLAX IMPLANTABLE CARDIOVERTER DIFIBRILLATOR SYSTEM
FDA premarket approval P980023/S032 · decided 2008-06-02
Approval details
- PMA number
- P980023
- Supplement
- S032
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- PHYLAX IMPLANTABLE CARDIOVERTER DIFIBRILLATOR SYSTEM
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Biotronik, Inc.
- Date received
- 2008-05-14
- Decision date
- 2008-06-02
- Days to decision
- 19 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Lake Oswego, OR
- Statement
- APPROVAL FOR PROGRAMMER SOFTWARE VERSION 801.U.
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510(k) clearances by this applicant
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