PMA P010012S038
- Device
- CONTAK RENEWAL 1 CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S038
- Product code
- LWP
- Decision date
- 2004-12-15
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- ADDITION OF AN ADHESIVE, A NEW MANUFACTURING STEP, AND PRE-FORMING OF A WIRE.
Current openFDA PMA Record#
- Device
- CONTAK RENEWAL 1 CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S038
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2004-12-15
- Decision code
- OK30
- Date received
- 2004-11-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADDITION OF AN ADHESIVE, A NEW MANUFACTURING STEP, AND PRE-FORMING OF A WIRE.