SYMPHONY 2550 AND 2250 & RHAPSODY 2530, 2510 AND 2210
FDA premarket approval P950029/S028 · decided 2006-09-15
Approval details
- PMA number
- P950029
- Supplement
- S028
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SYMPHONY 2550 AND 2250 & RHAPSODY 2530, 2510 AND 2210
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2006-08-18
- Decision date
- 2006-09-15
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- CHANGE FROM CLEANING WITH THE KERRY MACHINE TO CLEANING WITH THE MBTECH MACHINE, AND THE ADDITION OF AN MBTECH CLEANING STEP AND VISUAL INSPECTION STEP.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.