REPLY/ESPRIT PACEMAKER IMPLANTABLE MEDICAL DEVICES
FDA premarket approval P950029/S061 · decided 2011-08-29
Approval details
- PMA number
- P950029
- Supplement
- S061
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- REPLY/ESPRIT PACEMAKER IMPLANTABLE MEDICAL DEVICES
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2011-08-03
- Decision date
- 2011-08-29
- Days to decision
- 26 days
- Decision code
- OK30
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- CHANGE TO THE REFLOW SOLDERING PROFILE AND AN ALTERNATE TOOLING USED FOR THE PASSING OVEN.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.