BRAVA CRT-D'S; BRAVA QUAD CRT-D'S; CONCERTO II CRT-D; CONSULTA CRT-D; MAXIMO II CRT-D; PROTECTA CRT-D; PROTECTA XT CRT
FDA premarket approval P010031/S480 · decided 2015-02-09
Approval details
- PMA number
- P010031
- Supplement
- S480
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- BRAVA CRT-D'S; BRAVA QUAD CRT-D'S; CONCERTO II CRT-D; CONSULTA CRT-D; MAXIMO II CRT-D; PROTECTA CRT-D; PROTECTA XT CRT
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2015-01-12
- Decision date
- 2015-02-09
- Days to decision
- 28 days
- Decision code
- OK30
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- IMPLEMENTATION OF AN ADDITIONAL WELD STRENGTH PROOF TEST.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.