VIRTUOSO ICDS
FDA premarket approval P980016/S093 · decided 2007-01-11
Approval details
- PMA number
- P980016
- Supplement
- S093
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- VIRTUOSO ICDS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2006-12-14
- Decision date
- 2007-01-11
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- REDUCTION IN THE NUMBER OF SEAMWELD PENETRATION MONITORING SAMPLES AND A MINOR MODIFICATION IN PROCESSING OF SEAMWELD DATA.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.