PMA P860027S011
- Device
- MAESTRO(R) II MODEL 533 PACEMAKER SYSTEM
- Applicant
- Cardiac Control Systems, Inc.
- PMA number
- P860027
- Supplement
- S011
- Product code
- LWP
- Decision date
- 1996-07-09
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- APPROVAL FOR AN ALTERNATE STERILIZATION PROCEDURE
Current openFDA PMA Record#
- Device
- MAESTRO(R) II MODEL 533 PACEMAKER SYSTEM
- Applicant
- Cardiac Control Systems, Inc.
- PMA number
- P860027
- Supplement
- S011
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 1996-07-09
- Decision code
- APPR
- Date received
- 1995-12-26
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR AN ALTERNATE STERILIZATION PROCEDURE