PARADYM CRT-D, PARADYM RF CRT-D
FDA premarket approval P060027/S050 · decided 2013-05-03
Approval details
- PMA number
- P060027
- Supplement
- S050
- Supplement type
- 30-Day Notice
- Trade name
- PARADYM CRT-D, PARADYM RF CRT-D
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2013-04-10
- Decision date
- 2013-05-03
- Days to decision
- 23 days
- Decision code
- OK30
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- EXTENDING THE USE OF A PLASMA CLEANING STEP USED DURING THE MICRO-ELECTRONIC ASSEMBLY PROCESS.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.