INTENSIA CRT-D
FDA premarket approval P060027/S066 · decided 2014-11-04
Approval details
- PMA number
- P060027
- Supplement
- S066
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- INTENSIA CRT-D
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2014-05-15
- Decision date
- 2014-11-04
- Days to decision
- 173 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- APPROVAL FOR THE INTENSIA ICD AND CRT-D 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.