FDA PMA
FDA Class 3
Approved (Withdrawn)
🇺🇸 United States
Pulse-Generator, Single Chamber, Single
PMA: P860007
·
Decision Dec 31, 1986
Classifications
1
FEI Numbers
0
Registration Numbers
0
Basic Information
- Device Name
- Pulse-Generator, Single Chamber, Single
- Trade Name
- INTERTACH TM IMPLANTABLE PACEMAKER PULSE
- PMA Number
- P860007
- Device Class
- FDA Class 3
- Product Code
- LWW
- Generic Name
- PULSE-GENERATOR, SINGLE CHAMBER, SINGLE
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- Approved (Withdrawn)
- Decision Code
- APWD
- Decision Date
- December 31, 1986
- Date Received
- March 3, 1986
- Expedited Review
- N
- Docket Number
- 87M-0031
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LWW | Pulse-Generator, Single Chamber, Single | FDA class 3 | Unknown |