PROTECTA/PROTECTA XT CRT-D
FDA premarket approval P010031/S256 · decided 2011-06-10
Approval details
- PMA number
- P010031
- Supplement
- S256
- Supplement type
- 30-Day Notice
- Trade name
- PROTECTA/PROTECTA XT CRT-D
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2011-05-13
- Decision date
- 2011-06-10
- Days to decision
- 28 days
- Decision code
- OK30
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- CHANGE THE CLEANING AREA OF THE DEVICES.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.