PMA P880038S033
- Device
- META(TM) III PULSE GENERATOR MODELS 1206, 1206E, 1206M
- Applicant
- St. Jude Medical, Inc.
- PMA number
- P880038
- Supplement
- S033
- Product code
- DXY
- Decision date
- 1996-09-30
- Generic name
- implantable pacemaker Pulse-generator
- Approval order statement
- APPROVAL FOR AMODIFICATION TO THE LABELING REGARDING THE PROPER INSERTIO OF A LEAD INTO THE CONNECTOR PORT
Current openFDA PMA Record
- Device
- META(TM) III PULSE GENERATOR MODELS 1206, 1206E, 1206M
- Applicant
- St. Jude Medical, Inc.
- PMA number
- P880038
- Supplement
- S033
- Product code
- DXY
- Generic name
- implantable pacemaker Pulse-generator
- Decision date
- 1996-09-30
- Decision code
- APPR
- Date received
- 1996-08-09
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR AMODIFICATION TO THE LABELING REGARDING THE PROPER INSERTIO OF A LEAD INTO THE CONNECTOR PORT