REPLY/ESPRIT PACEMAKER FAMILY
FDA premarket approval P950029/S076 · decided 2013-03-14
Approval details
- PMA number
- P950029
- Supplement
- S076
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- REPLY/ESPRIT PACEMAKER FAMILY
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2013-02-19
- Decision date
- 2013-03-14
- Days to decision
- 23 days
- Decision code
- OK30
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- MODIFICATIONS TO THE LASER WELDING 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.