PROTECTA CRT-D, PROTECTA XT CRT-D
FDA premarket approval P010031/S291 · decided 2012-03-09
Approval details
- PMA number
- P010031
- Supplement
- S291
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- PROTECTA CRT-D, PROTECTA XT CRT-D
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2012-02-13
- Decision date
- 2012-03-09
- Days to decision
- 25 days
- Decision code
- OK30
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- ADD ADDITIONAL MODELS THAT WERE NOT INCLUDED IN A PREVIOUSLY APPROVED 30-DAY NOTICE REGARDING THE IMPLEMENTATION OF MATERIAL ANALYSIS AND QUALIFICATION SYSTEM (MAQS) FOR INCOMING INSPECTION.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.