MAXIMO II ICD, PROTECTA ICD,PROTECTA XT ICD, SECURA ICD, VIRTUOSO II DR/VR ICD
FDA premarket approval P980016/S372 · decided 2012-08-27
Approval details
- PMA number
- P980016
- Supplement
- S372
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MAXIMO II ICD, PROTECTA ICD,PROTECTA XT ICD, SECURA ICD, VIRTUOSO II DR/VR ICD
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2012-07-31
- Decision date
- 2012-08-27
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- UPDATE TEST SOFTWARE AND HARDWARE ON THE TERADYNE TEST PLATFORM FOR M019 AND M017 INTEGRATED CIRCUITS.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.