VIRTUOSO ICDS
FDA premarket approval P980016/S185 · decided 2009-04-02
Approval details
- PMA number
- P980016
- Supplement
- S185
- Supplement type
- 30-Day Notice
- Trade name
- VIRTUOSO ICDS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2009-03-04
- Decision date
- 2009-04-02
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- MODIFICATION OF THE INCOMING VISUAL INSPECTION SAMPLING PLAN.
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