PARADYM VR 8750, PARADYM DR8750
FDA premarket approval P980049/S088 · decided 2013-10-29
Approval details
- PMA number
- P980049
- Supplement
- S088
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- PARADYM VR 8750, PARADYM DR8750
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2013-10-17
- Decision date
- 2013-10-29
- Days to decision
- 12 days
- Decision code
- OK30
- Product code
- MRM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- ADDITION OF ALTERNATIVE LASER WELDING EQUIPMENT AND A MODIFICATION TO THE LASER WELD PROGRAM.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.