PARADYM VR & DR
FDA premarket approval P980049/S066 · decided 2011-11-30
Approval details
- PMA number
- P980049
- Supplement
- S066
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- PARADYM VR & DR
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2011-10-31
- Decision date
- 2011-11-30
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- MRM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- USE OF AN ALTERNATE REFLOW OVEN WITH AN UPDATED REFLOW SOLDERING PROFILE AND AN ALTERNATE COMPONENT CARRIER.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.