PMA P950037S283
- Device
- DROMOS DR/DR-A AND DROMOS SR/SR-B CARDIAC PACING SYSTEMS
- Applicant
- Biotronik, Inc.
- PMA number
- P950037
- Supplement
- S283
- Product code
- DXY
- Decision date
- 2026-02-11
- Classification
- Cardiovascular
- Generic name
- implantable pacemaker Pulse-generator
- Approval order statement
- qualification of an alternate manufacturing site for printed circuit boards
Current openFDA PMA Record#
- Device
- DROMOS DR/DR-A AND DROMOS SR/SR-B CARDIAC PACING SYSTEMS
- Applicant
- Biotronik, Inc.
- PMA number
- P950037
- Supplement
- S283
- Product code
- DXY
- Generic name
- implantable pacemaker Pulse-generator
- Decision date
- 2026-02-11
- Decision code
- OK30
- Date received
- 2026-01-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- qualification of an alternate manufacturing site for printed circuit boards